Back to resultsStudy Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
Primary Purpose
Biliary Tract Surgical Procedures, Pancreaticoduodenectomy, Esophagectomy
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Tranexamic acid + Standard of Care
Standard of Care
Sponsored by
About this trial
This is an interventional prevention trial for Biliary Tract Surgical Procedures focused on measuring tranexamic acid, major abdominal surgery, blood loss
Eligibility Criteria
Inclusion Criteria:
- Patient undergoing major abdominal surgery (Biliary strictures, Pancreatico-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy, Gastrectomy, Other major abdominal surgeries with similar expected blood loss)
Exclusion Criteria:
- Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia.
- Patients with known coagulopathy.
- Patients with anemia (hemoglobin levels less than 8 mg/dl)
- Patients with documented DVT or PE at screening or in past three months.
- Patients with any associated major illness (e.g., severe cardiac or respiratory disease).
- Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
A
B
Arm Description
end of the operation and on the mornings of the first, second, fourth and seventh postoperative days.
Standard of Care
Outcomes
Primary Outcome Measures
Post-operative Blood Loss
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.
Secondary Outcome Measures
Intra-operative Blood Loss
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
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
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
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
Number of Participants With Deep Vein Thrombosis (DVT) 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00827931
Brief Title
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in various types of major surgery (orthopedic surgery, spine surgery, cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is being conducted to compare the efficacy of tranexamic acid plus standard of care versus standard of care in reduction of blood loss in patients undergoing major abdominal surgeries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Surgical Procedures, Pancreaticoduodenectomy, Esophagectomy, Colectomy, Gastrectomy
Keywords
tranexamic acid, major abdominal surgery, blood loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
end of the operation and on the mornings of the first, second, fourth and seventh postoperative days.
Arm Title
B
Arm Type
Other
Arm Description
Standard of Care
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid + Standard of Care
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss
Primary Outcome Measure Information:
Title
Post-operative Blood Loss
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
Secondary Outcome Measure Information:
Title
Intra-operative Blood Loss
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)
Title
Total Blood Loss
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
Title
Total Blood Loss as Assessed by the Gross' Formula
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
Title
Percentage of Participants Receiving Transfusions
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
Title
Hemoglobin Levels
Time Frame
End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery
Title
Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient undergoing major abdominal surgery (Biliary strictures, Pancreatico-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy, Gastrectomy, Other major abdominal surgeries with similar expected blood loss)
Exclusion Criteria:
Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia.
Patients with known coagulopathy.
Patients with anemia (hemoglobin levels less than 8 mg/dl)
Patients with documented DVT or PE at screening or in past three months.
Patients with any associated major illness (e.g., severe cardiac or respiratory disease).
Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Baroda
State/Province
Gujarat
ZIP/Postal Code
390 001
Country
India
Facility Name
Pfizer Investigational Site
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395 001
Country
India
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1461001&StudyName=Study%20Of%20Tranexamic%20Acid%20For%20The%20Reduction%20Of%20Blood%20Loss%20In%20Patients%20Undergoing%20Major%20Abdominal%20Surgery
Description
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Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
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