Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00827931
First received: January 22, 2009
Last updated: April 2, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Biliary Tract Surgical Procedures Pancreaticoduodenectomy Esophagectomy Colectomy Gastrectomy |
Drug: Tranexamic acid + Standard of Care Procedure: Standard of Care |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Post-operative Blood Loss [ Time Frame: Post-operation, Day 1, Day 2 up to drain removal ] [ Designated as safety issue: No ]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 [ Time Frame: Day 1 (End of surgery) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery [ Time Frame: Day 7 post-surgery ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 94 |
| Study Start Date: | September 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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)
|
|
B
Standard of Care
|
Procedure: Standard of Care
Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827931
Locations
| India | |
| Pfizer Investigational Site | |
| Baroda, Gujarat, India, 390 001 | |
| Pfizer Investigational Site | |
| Surat, Gujarat, India, 395 001 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00827931 History of Changes |
| Other Study ID Numbers: | B1461001 |
| Study First Received: | January 22, 2009 |
| Results First Received: | April 2, 2012 |
| Last Updated: | April 2, 2012 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Pfizer:
|
tranexamic acid major abdominal surgery blood loss |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013