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Trial record 4 of 10 for:    "Hereditary Antithrombin Deficiency" | "Antithrombin III"

Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00823082
Recruitment Status : Completed
First Posted : January 15, 2009
Results First Posted : August 4, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals, LLC ( Instituto Grifols, S.A. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Acquired Antithrombin III Deficiency
Coronary Artery Bypass
Intervention Drug: Antithrombin III
Enrollment 200
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Period Title: Overall Study
Started 100 100
Safety Population 100 99
Intent-to-Treat/Per Protocol Populations 100 94
Completed 100 99
Not Completed 0 1
Arm/Group Title Antithrombin III Treatment Group Control Group Total
Hide Arm/Group Description

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered Total of all reporting groups
Overall Number of Baseline Participants 100 94 194
Hide Baseline Analysis Population Description
206 subjects were randomized; six were screen failures. 100 subjects in the Anbinex treatment group and 94 subjects in the control group were included in the Intent-to-treat and Per-protocol populations (6 subjects in the control group were excluded). 199 subject were included in the Safety population (100 Anbinex and 99 control).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 94 participants 194 participants
66.51  (10.48) 67.63  (11.18) 67.05  (10.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 94 participants 194 participants
Female
17
  17.0%
24
  25.5%
41
  21.1%
Male
83
  83.0%
70
  74.5%
153
  78.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 100 participants 94 participants 194 participants
100 94 194
1.Primary Outcome
Title Postoperative ATIII Levels at the ICU Admission
Hide Description Measurement of postoperative ATIII functional activity at ICU admission
Time Frame ICU admission
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat set and Per-protocol set
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 100 94
Mean (Standard Deviation)
Unit of Measure: IU
94.06  (13.74) 64.70  (9.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission
Hide Description Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission
Time Frame ICU admission
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to treat set and Per-protocol set
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 100 94
Measure Type: Number
Unit of Measure: percentage of participants
100.0 74.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Subjects With Postoperative Myocardial Infarction
Hide Description Percentage of subjects with postoperative myocardial infarction defined through enzymatic criteria plus new Q-waves at the electrocardiogram
Time Frame During ICU stay (maximum 70 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat set
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 100 94
Measure Type: Number
Unit of Measure: percentage of participants
Follow-up visit (Anbinex n=76, Control n=69) 0.0 0.0
ICU discharge visit (Anbinex n=99, Control n=93) 1.0 2.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments At ICU discharge visit
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6115
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Subjects With Adverse Neurologic Outcome
Hide Description Percentage of subjects with adverse neurologic outcome defined as: coma, stroke or psychotic behaviors lasting >12 hours after extubation
Time Frame During ICU stay (maximum 70 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat set
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 100 94
Measure Type: Number
Unit of Measure: percentage of participants
Follow-up visit (Anbinex n=75, Control n=69) 5.3 0.0
ICU discharge visit (Anbinex n=99, Control n=93) 1.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments Follow-up visit
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1211
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments ICU discharge visit
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Patients With Thromboembolic Events
Hide Description Percentage of subjects with thromboembolic events defined as perioperative myocardial infarction, stroke, mesenteric infarction, peripheral thromboembolism and pulmonary embolism
Time Frame During ICU stay (maximum 70 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat set
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 100 94
Measure Type: Number
Unit of Measure: percentage of participants
Follow-up visit (Anbinex n=76, Control n=69) 0.0 0.0
ICU discharge visit (Anbinex n=99, Control n=94) 0.0 1.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments ICU discharge visit
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4870
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title ICU Stay Duration
Hide Description [Not Specified]
Time Frame During ICU stay (maximum 70 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat set. One subject in the control group was missing this data.
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 100 93
Median (Inter-Quartile Range)
Unit of Measure: days
2.00
(1.00 to 4.00)
2.00
(1.00 to 3.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3897
Comments [Not Specified]
Method Hodges-Lehmann test
Comments [Not Specified]
7.Secondary Outcome
Title In-hospital Postoperative Mortality
Hide Description [Not Specified]
Time Frame 70 days after ICU admission (maximum)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat set. One subject in the control group was missing this data.
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 100 93
Measure Type: Number
Unit of Measure: percentage of participants
1.0 1.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Heparin Resistance
Hide Description Percentage of subjects with heparin resistance defined as failure to reach an activated clotting time >450 seconds after a dose of up to 400 IU/kg of heparin, or failure to maintain this activated clotting time value despite heparin supplementations of 100 IU/kg per each dose with an interval of at least 30 minutes between doses
Time Frame Immediately after anesthesia induction
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat set. One subject in the Antithrombin III treatment group was missing this data.
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 99 94
Measure Type: Number
Unit of Measure: percentage of participants
17.2 40.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Postoperative Blood Loss in First 12 Hours
Hide Description Blood loss defined as the amount of blood collected in the cardiotomy reservoir from ICU admission through the following 12 hours
Time Frame ICU admission through 12 hours post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat set. One subject in the Antithrombin III treatment group was missing this data.
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 99 94
Least Squares Mean (Standard Error)
Unit of Measure: mL
516.11  (30.292) 415.00  (31.087)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0209
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title Need for Blood Products
Hide Description Number of units of packed red blood cells, fresh frozen plasma, and/or platelets needed
Time Frame During ICU stay (maximum 70 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat set
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 100 94
Least Squares Mean (Standard Error)
Unit of Measure: Units
Packed Red Blood Cells (Anbinex n=45,Control n=38) 43.711  (3.551) 41.987  (3.864)
Fresh frozen plasma (Anbinex n=16, Control n=8) 12.188  (1.646) 13.125  (2.327)
Platelets (Anbinex n=5, Control n=8) 8.500  (1.564) 6.188  (1.236)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments Number of units of packed red blood cells
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7433
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments Units of fresh frozen plasma
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7453
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments Units of platelets
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2705
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Subjects Needing Surgical Re-exploration
Hide Description Percentage of subjects needing surgical re-exploration resulting from bleeding
Time Frame During ICU stay (maximum 70 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat set. Two subjects in the Antithrombin III treatment group and 2 subjects in the Control group were missing this data.
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 98 92
Measure Type: Number
Unit of Measure: percentage of participants
5.1 2.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4460
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Subjects With Low Cardiac Syndrome
Hide Description Percentage of subjects with low cardiac syndrome defined as the need for major inotropic support or intra-aortic balloon pump
Time Frame During ICU stay (maximum 70 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat set. Three subjects in the Antithrombin III treatment group and 1 subject in the Control group were missing this data.
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 97 93
Measure Type: Number
Unit of Measure: percentage of participants
24.7 20.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4936
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Subjects With Renal Dysfunction
Hide Description Percentage of subjects with renal dysfunction defined as an increase of serum creatinine levels to >2.0 and twice the baseline level or need for renal replacement therapy
Time Frame During ICU stay (maximum 70 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat set
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 100 94
Measure Type: Number
Unit of Measure: Percentage of participants
Follow-up visit (Anbinex n=75, Control n=69) 1.3 0.0
ICU discharge visit (Anbinex n=99, Control n=93) 3.0 1.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments Follow-up visit
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments ICU discharge visit
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6218
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
14.Secondary Outcome
Title Mechanical Ventilation Duration
Hide Description [Not Specified]
Time Frame During ICU stay (maximum 70 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat set
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 100 94
Median (Inter-Quartile Range)
Unit of Measure: Days
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9574
Comments [Not Specified]
Method Hodges-Lehmann
Comments [Not Specified]
15.Secondary Outcome
Title Length of Hospital Stay
Hide Description Length of hospital stay (days) in both groups was defined as the discharge date minus the surgery date plus 1 day, during a maximum of 70 days after ICU admission.
Time Frame During ICU stay (maximum 70 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description:

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATIII supplementation administered
Overall Number of Participants Analyzed 100 94
Median (Inter-Quartile Range)
Unit of Measure: days
10.00
(8.00 to 13.50)
10.00
(8.00 to 13.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antithrombin III Treatment Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7489
Comments [Not Specified]
Method Hodges-Lehmann test
Comments [Not Specified]
Time Frame From the time of the Recruitment Visit (Day -14) to the Follow-up Visit (Day 50 +/- 20 days)
Adverse Event Reporting Description 206 subjects were randomized; six were screen failures. 199 subject were included in the Safety population (100 Anbinex and 99 control).One subject in the control group was excluded from the safety population as Anbinex was administered during the ICU stay.
 
Arm/Group Title Antithrombin III Treatment Group Control Group
Hide Arm/Group Description

Preoperative ATIII supplementation administered immediately after anesthesia induction

Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

No preoperative ATII supplementation administered
All-Cause Mortality
Antithrombin III Treatment Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Antithrombin III Treatment Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/100 (32.00%)      29/99 (29.29%)    
Blood and lymphatic system disorders     
Leukocytosis  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Thrombocytopenia  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Cardiac disorders     
Atrial fibrillation  1  22/100 (22.00%)  22 17/99 (17.17%)  17
Atrial flutter  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Bradycardia  1  0/100 (0.00%)  0 2/99 (2.02%)  2
Cardiac arrest  1  2/100 (2.00%)  3 0/99 (0.00%)  0
Cardiac tamponade  1  1/100 (1.00%)  1 1/99 (1.01%)  1
Cardio-respiratory arrest  1  0/100 (0.00%)  0 2/99 (2.02%)  2
Low cardiac output syndrome  1  1/100 (1.00%)  1 3/99 (3.03%)  3
Myocardial infarction  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Ventricular fibrillation  1  0/100 (0.00%)  0 2/99 (2.02%)  2
Ventricular hypokinesia  1  0/100 (0.00%)  0 1/99 (1.01%)  1
General disorders     
Device occlusion  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Hyperpyrexia  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Pyrexia  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Infections and infestations     
Acinetobacter infection  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Endocarditis  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Klebsiella infection  1  2/100 (2.00%)  2 0/99 (0.00%)  0
Pseudomonas infection  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Sepsis  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Serratia infection  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Staphyloccal infection  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Wound infection Staphyloccal  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Septic shock  1  2/100 (2.00%)  2 0/99 (0.00%)  0
Injury, poisoning and procedural complications     
Graft thrombosis  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Post procedural hemorrhage  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Vasoplegia syndrome  1  2/100 (2.00%)  2 0/99 (0.00%)  0
Wound secretion  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Investigations     
Electrocardiogram ST segment elevation  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Enterococcus test positive  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Seroconversion test  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Staphylcoccus test positive  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle necrosis  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Nervous system disorders     
Cerebral hematoma  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Cerebral hemorrhage  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Coma  1  2/100 (2.00%)  2 0/99 (0.00%)  0
Psychiatric disorders     
Psychotic behavior  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Renal and urinary disorders     
Oliguria  1  2/100 (2.00%)  2 0/99 (0.00%)  0
Renal failure  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary edema  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Acute respiratory distress  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Bronchospasm  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Dyspnoea  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Hypoxia  1  2/100 (2.00%)  2 1/99 (1.01%)  1
Pleural effusion  1  0/100 (0.00%)  0 2/99 (2.02%)  2
Pneumothorax  1  1/100 (1.00%)  1 1/99 (1.01%)  1
Respiratory failure  1  1/100 (1.00%)  1 1/99 (1.01%)  1
Surgical and medical procedures     
Evidence based treatment  1  0/100 (0.00%)  0 2/99 (2.02%)  2
Hospitalization  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Tricuspid valve repair  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Vascular disorders     
Hemodynamic instability  1  1/100 (1.00%)  1 0/99 (0.00%)  0
Hemorrhage  1  2/100 (2.00%)  2 1/99 (1.01%)  1
Hypertension  1  0/100 (0.00%)  0 1/99 (1.01%)  1
Hypotension  1  1/100 (1.00%)  1 1/99 (1.01%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Antithrombin III Treatment Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   96/100 (96.00%)      97/99 (97.98%)    
Blood and lymphatic system disorders     
Leukocytosis  1  12/100 (12.00%)  12 11/99 (11.11%)  11
Cardiac disorders     
Atrial fibrillation  1  24/100 (24.00%)  24 17/99 (17.17%)  17
Atrioventricular block  1  5/100 (5.00%)  5 2/99 (2.02%)  2
Bradycardia  1  23/100 (23.00%)  23 12/99 (12.12%)  12
Pericardial effusion  1  5/100 (5.00%)  5 5/99 (5.05%)  5
Sinus tachycardia  1  4/100 (4.00%)  4 5/99 (5.05%)  5
Supraventricular extrasystoles  1  8/100 (8.00%)  8 6/99 (6.06%)  6
Tachycardia  1  21/100 (21.00%)  21 17/99 (17.17%)  17
Sinus bradycardia  1  0/100 (0.00%)  0 7/99 (7.07%)  7
General disorders     
Oedema peripheral  1  16/100 (16.00%)  16 15/99 (15.15%)  15
Pyrexia  1  38/100 (38.00%)  38 42/99 (42.42%)  45
Serositis  1  6/100 (6.00%)  6 5/99 (5.05%)  5
Investigations     
Electrocardiogram ST segment elevation  1  5/100 (5.00%)  5 4/99 (4.04%)  4
Hematocrit decreased  1  22/100 (22.00%)  22 6/99 (6.06%)  7
Psychiatric disorders     
Disorientation  1  6/100 (6.00%)  6 1/99 (1.01%)  1
Renal and urinary disorders     
Oliguria  1  7/100 (7.00%)  7 2/99 (2.02%)  2
Respiratory, thoracic and mediastinal disorders     
Bronchospasm  1  3/100 (3.00%)  3 6/99 (6.06%)  6
Dyspnoa  1  6/100 (6.00%)  6 3/99 (3.03%)  3
Hypoxia  1  10/100 (10.00%)  10 10/99 (10.10%)  10
Increased bronchial secretion  1  9/100 (9.00%)  9 5/99 (5.05%)  5
Pleural effusion  1  47/100 (47.00%)  47 45/99 (45.45%)  45
Skin and subcutaneous tissue disorders     
Subcutaneous emphysema  1  5/100 (5.00%)  5 0/99 (0.00%)  0
Surgical and medical procedures     
Diuretic therapy  1  15/100 (15.00%)  15 15/99 (15.15%)  15
Vascular disorders     
Hemorrhage  1  27/100 (27.00%)  27 23/99 (23.23%)  23
Hypertension  1  8/100 (8.00%)  8 10/99 (10.10%)  11
Hypotension  1  11/100 (11.00%)  11 13/99 (13.13%)  13
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Site may publish results from the Study, after providing Sponsor thirty days’ notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsor’s request, Site will remove any Confidential Information (other than Study results), and Site will upon Sponsor’s request, delay publication or presentation for a period of up to one hundred twenty days to allow Sponsor to protect its interests in any Sponsor’s Inventions.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Ken Woodward, BSc, M.Sc
Organization: GrifolsTherapeutics Inc.
Phone: +1 919-316-6675
EMail: michael.woodward@grifols.com
Layout table for additonal information
Responsible Party: Grifols Biologicals, LLC ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier: NCT00823082     History of Changes
Other Study ID Numbers: IG0801
First Submitted: January 14, 2009
First Posted: January 15, 2009
Results First Submitted: April 5, 2016
Results First Posted: August 4, 2016
Last Update Posted: September 20, 2016