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Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery

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: NCT00827931
Recruitment Status : Completed
First Posted : January 23, 2009
Results First Posted : April 26, 2012
Last Update Posted : April 26, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Biliary Tract Surgical Procedures
Pancreaticoduodenectomy
Esophagectomy
Colectomy
Gastrectomy
Interventions Drug: Tranexamic acid + Standard of Care
Procedure: Standard of Care
Enrollment 94
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tranexamic Acid Plus Standard of Care Standard of Care
Hide Arm/Group Description Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss). Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
Period Title: Overall Study
Started 49 45
Completed 43 39
Not Completed 6 6
Reason Not Completed
Death             3             5
Adverse Event             1             0
Lost to Follow-up             1             0
Withdrawal by Subject             0             1
Other             1             0
Arm/Group Title Tranexamic Acid Plus Standard of Care Standard of Care Total
Hide Arm/Group Description Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss). Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss. Total of all reporting groups
Overall Number of Baseline Participants 49 45 94
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 49 participants 45 participants 94 participants
18 to 44 years 24 16 40
45 to 64 years 21 22 43
Greater than or equal to 65 years 4 7 11
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 45 participants 94 participants
Female
16
  32.7%
16
  35.6%
32
  34.0%
Male
33
  67.3%
29
  64.4%
62
  66.0%
1.Primary Outcome
Title Post-operative Blood Loss
Hide Description Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
Time Frame Post-operation, Day 1, Day 2 up to drain removal
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.
Arm/Group Title Tranexamic Acid Plus Standard of Care Standard of Care
Hide Arm/Group Description:
Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: milliliter (mL)
394.3  (366.36) 494.3  (503.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tranexamic Acid Plus Standard of Care, Standard of Care
Comments The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.460
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -99.9
Confidence Interval (2-Sided) 95%
-371.4 to 171.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 131.99
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Intra-operative Blood Loss
Hide Description Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
Time Frame Day 1 (End of surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.
Arm/Group Title Tranexamic Acid Plus Standard of Care Standard of Care
Hide Arm/Group Description:
Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: mL
599.2  (419.58) 682.8  (555.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tranexamic Acid Plus Standard of Care, Standard of Care
Comments The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.579
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -83.6
Confidence Interval (2-Sided) 95%
-386.5 to 219.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 147.61
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Total Blood Loss
Hide Description Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
Time Frame Baseline through Day 2 post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.
Arm/Group Title Tranexamic Acid Plus Standard of Care Standard of Care
Hide Arm/Group Description:
Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: mL
993.6  (703.63) 1177.1  (879.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tranexamic Acid Plus Standard of Care, Standard of Care
Comments The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.452
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -183.5
Confidence Interval (2-Sided) 95%
-672.6 to 305.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 239.19
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Total Blood Loss as Assessed by the Gross' Formula
Hide Description Gross' formula for estimating total blood loss: Estimated blood volume multiplied by (*) [(hematocrit initial minus hematocrit final) divided by hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.
Time Frame Baseline through Day 2 post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.
Arm/Group Title Tranexamic Acid Plus Standard of Care Standard of Care
Hide Arm/Group Description:
Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: mL
17.8  (451.24) 435.5  (558.74)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tranexamic Acid Plus Standard of Care, Standard of Care
Comments The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -417.7
Confidence Interval (2-Sided) 95%
-729.4 to -106.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 152.51
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Receiving Transfusions
Hide Description A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dL) hemoglobin or hematocrit value of 24 percent.
Time Frame Up to Day 7 post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.
Arm/Group Title Tranexamic Acid Plus Standard of Care Standard of Care
Hide Arm/Group Description:
Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
21.7
(7.5 to 43.7)
14.3
(3.0 to 36.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tranexamic Acid Plus Standard of Care, Standard of Care
Comments Fisher's exact test was used at 5% level of significance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.701
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Hemoglobin Levels
Hide Description [Not Specified]
Time Frame End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.
Arm/Group Title Tranexamic Acid Plus Standard of Care Standard of Care
Hide Arm/Group Description:
Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: Gram/Deciliter (g/dL)
End of surgery 11.6  (2.16) 12.1  (1.30)
Day 1 11.3  (1.44) 11.6  (1.41)
Day 2 10.4  (1.70) 11.0  (1.41)
Day 4 10.8  (1.67) 10.9  (1.39)
Day 7/EoT 11.0  (1.38) 11.1  (1.60)
7.Secondary Outcome
Title Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery
Hide Description DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth.
Time Frame Day 7 post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.
Arm/Group Title Tranexamic Acid Plus Standard of Care Standard of Care
Hide Arm/Group Description:
Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: Participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Tranexamic Acid Plus Standard of Care Standard of Care
Hide Arm/Group Description Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss). Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
All-Cause Mortality
Tranexamic Acid Plus Standard of Care Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Tranexamic Acid Plus Standard of Care Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   9/49 (18.37%)   7/45 (15.56%) 
Cardiac disorders     
Bradycardia * 1  0/49 (0.00%)  1/45 (2.22%) 
Cardio-respiratory arrest * 1  2/49 (4.08%)  3/45 (6.67%) 
Myocardial infarction * 1  0/49 (0.00%)  1/45 (2.22%) 
Gastrointestinal disorders     
Intestinal obstruction * 1  0/49 (0.00%)  1/45 (2.22%) 
Vomiting * 1  1/49 (2.04%)  0/45 (0.00%) 
General disorders     
Asthenia * 1  1/49 (2.04%)  0/45 (0.00%) 
Hepatobiliary disorders     
Biliary tract disorder * 1  1/49 (2.04%)  1/45 (2.22%) 
Infections and infestations     
Infectious peritonitis * 1  1/49 (2.04%)  1/45 (2.22%) 
Sepsis * 1  1/49 (2.04%)  0/45 (0.00%) 
Septic shock * 1  1/49 (2.04%)  0/45 (0.00%) 
Injury, poisoning and procedural complications     
Biliary anastomosis complication * 1  0/49 (0.00%)  1/45 (2.22%) 
Post procedural complication * 1  1/49 (2.04%)  0/45 (0.00%) 
Suture rupture * 1  2/49 (4.08%)  0/45 (0.00%) 
Metabolism and nutrition disorders     
Hypokalaemia * 1  1/49 (2.04%)  0/45 (0.00%) 
Nervous system disorders     
Convulsion * 1  0/49 (0.00%)  1/45 (2.22%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  0/49 (0.00%)  2/45 (4.44%) 
Aspiration * 1  0/49 (0.00%)  1/45 (2.22%) 
Pneumonitis * 1  1/49 (2.04%)  0/45 (0.00%) 
Respiratory distress * 1  1/49 (2.04%)  0/45 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tranexamic Acid Plus Standard of Care Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   22/49 (44.90%)   14/45 (31.11%) 
Blood and lymphatic system disorders     
Anaemia * 1  5/49 (10.20%)  1/45 (2.22%) 
Thrombocytopenia * 1  1/49 (2.04%)  0/45 (0.00%) 
Gastrointestinal disorders     
Ascites * 1  2/49 (4.08%)  0/45 (0.00%) 
Diarrhoea * 1  1/49 (2.04%)  0/45 (0.00%) 
Nausea * 1  0/49 (0.00%)  1/45 (2.22%) 
Vomiting * 1  1/49 (2.04%)  1/45 (2.22%) 
General disorders     
Pain * 1  1/49 (2.04%)  0/45 (0.00%) 
Pyrexia * 1  2/49 (4.08%)  1/45 (2.22%) 
Infections and infestations     
Abscess * 1  0/49 (0.00%)  1/45 (2.22%) 
Post procedural infection * 1  1/49 (2.04%)  0/45 (0.00%) 
Injury, poisoning and procedural complications     
Cardiac procedure complication * 1  1/49 (2.04%)  0/45 (0.00%) 
Procedural hypertension * 1  1/49 (2.04%)  0/45 (0.00%) 
Procedural pain * 1  4/49 (8.16%)  4/45 (8.89%) 
Investigations     
Blood glucose increased * 1  0/49 (0.00%)  1/45 (2.22%) 
Blood pressure decreased * 1  1/49 (2.04%)  2/45 (4.44%) 
Haematocrit decreased * 1  1/49 (2.04%)  3/45 (6.67%) 
Haemoglobin decreased * 1  1/49 (2.04%)  3/45 (6.67%) 
Metabolism and nutrition disorders     
Hypokalaemia * 1  2/49 (4.08%)  0/45 (0.00%) 
Nervous system disorders     
Bradykinesia * 1  0/49 (0.00%)  1/45 (2.22%) 
Headache * 1  0/49 (0.00%)  1/45 (2.22%) 
Psychiatric disorders     
Delirium * 1  0/49 (0.00%)  1/45 (2.22%) 
Sleep disorder * 1  1/49 (2.04%)  0/45 (0.00%) 
Skin and subcutaneous tissue disorders     
Urticaria * 1  0/49 (0.00%)  1/45 (2.22%) 
Urticaria contact * 1  0/49 (0.00%)  1/45 (2.22%) 
Vascular disorders     
Deep vein thrombosis * 1  1/49 (2.04%)  0/45 (0.00%) 
Hypertension * 1  2/49 (4.08%)  0/45 (0.00%) 
Hypotension * 1  4/49 (8.16%)  1/45 (2.22%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v14.1
The intended FAS population was planned to include participants from 2 sites, however due to non-reliability of data from one of the sites, the actual FAS population included participants from a single site only.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00827931    
Other Study ID Numbers: B1461001
First Submitted: January 22, 2009
First Posted: January 23, 2009
Results First Submitted: April 2, 2012
Results First Posted: April 26, 2012
Last Update Posted: April 26, 2012