Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
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|ClinicalTrials.gov Identifier: NCT00827931|
Recruitment Status : Completed
First Posted : January 23, 2009
Results First Posted : April 26, 2012
Last Update Posted : April 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Surgical Procedures Pancreaticoduodenectomy Esophagectomy Colectomy Gastrectomy||Drug: Tranexamic acid + Standard of Care Procedure: Standard of Care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Vs Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||May 2011|
end of the operation and on the mornings of the first, second, fourth and seventh postoperative days.
Drug: Tranexamic acid + Standard of Care
Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss)
Standard of Care
Procedure: Standard of Care
Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss
- Post-operative Blood Loss [ Time Frame: Post-operation, Day 1, Day 2 up to drain removal ]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.
- Intra-operative Blood Loss [ Time Frame: Day 1 (End of surgery) ]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.
- Total Blood Loss [ Time Frame: Baseline through Day 2 post-surgery ]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.
- Total Blood Loss as Assessed by the Gross' Formula [ Time Frame: Baseline through Day 2 post-surgery ]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.
- Percentage of Participants Receiving Transfusions [ Time Frame: Up to Day 7 post-surgery ]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.
- Hemoglobin Levels [ Time Frame: End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery ]
- Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery [ Time Frame: Day 7 post-surgery ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827931
|Pfizer Investigational Site|
|Baroda, Gujarat, India, 390 001|
|Pfizer Investigational Site|
|Surat, Gujarat, India, 395 001|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|