Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier:
NCT00823082
First received: January 14, 2009
Last updated: June 23, 2016
Last verified: June 2016
Results First Received: April 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Acquired Antithrombin III Deficiency
Coronary Artery Bypass
Intervention: Drug: Antithrombin III

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Antithrombin III Treatment Group

Preoperative ATIII supplementation administered immediately after anesthesia induction

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

Control Group No preoperative ATIII supplementation administered

Participant Flow:   Overall Study
    Antithrombin III Treatment Group     Control Group  
STARTED     100     100  
Safety Population     100     99  
Intent-to-Treat/Per Protocol Populations     100     94  
COMPLETED     100     99  
NOT COMPLETED     0     1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Antithrombin III Treatment Group

Preoperative ATIII supplementation administered immediately after anesthesia induction

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

Control Group No preoperative ATIII supplementation administered
Total Total of all reporting groups

Baseline Measures
    Antithrombin III Treatment Group     Control Group     Total  
Number of Participants  
[units: participants]
  100     94     194  
Age  
[units: years]
Mean (Standard Deviation)
  66.51  (10.48)     67.63  (11.18)     67.05  (10.81)  
Gender  
[units: participants]
     
Female     17     24     41  
Male     83     70     153  
Region of Enrollment  
[units: participants]
     
Italy     100     94     194  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Postoperative ATIII Levels at the ICU Admission   [ Time Frame: ICU admission ]

2.  Primary:   Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission   [ Time Frame: ICU admission ]

3.  Secondary:   Percentage of Subjects With Postoperative Myocardial Infarction   [ Time Frame: During ICU stay (maximum 70 days) ]

4.  Secondary:   Percentage of Subjects With Adverse Neurologic Outcome   [ Time Frame: During ICU stay (maximum 70 days) ]

5.  Secondary:   Percentage of Patients With Thromboembolic Events   [ Time Frame: During ICU stay (maximum 70 days) ]

6.  Secondary:   ICU Stay Duration   [ Time Frame: During ICU stay (maximum 70 days) ]

7.  Secondary:   In-hospital Postoperative Mortality   [ Time Frame: 70 days after ICU admission (maximum) ]

8.  Secondary:   Heparin Resistance   [ Time Frame: Immediately after anesthesia induction ]

9.  Secondary:   Postoperative Blood Loss in First 12 Hours   [ Time Frame: ICU admission through 12 hours post-operative ]

10.  Secondary:   Need for Blood Products   [ Time Frame: During ICU stay (maximum 70 days) ]

11.  Secondary:   Percentage of Subjects Needing Surgical Re-exploration   [ Time Frame: During ICU stay (maximum 70 days) ]

12.  Secondary:   Percentage of Subjects With Low Cardiac Syndrome   [ Time Frame: During ICU stay (maximum 70 days) ]

13.  Secondary:   Percentage of Subjects With Renal Dysfunction   [ Time Frame: During ICU stay (maximum 70 days) ]

14.  Secondary:   Mechanical Ventilation Duration   [ Time Frame: During ICU stay (maximum 70 days) ]

15.  Secondary:   Length of Hospital Stay   [ Time Frame: During ICU stay (maximum 70 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Michael Ken Woodward, BSc, M.Sc
Organization: GrifolsTherapeutics Inc.
phone: +1 919-316-6675
e-mail: michael.woodward@grifols.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier: NCT00823082     History of Changes
Other Study ID Numbers: IG0801
Study First Received: January 14, 2009
Results First Received: April 5, 2016
Last Updated: June 23, 2016
Health Authority: Italy: The Italian Medicines Agency