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

Pancreaticoduodenectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827931
• Other study ID #: B1461001
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2009
• Last updated: April 2, 2012
• Start date: September 2009
• Est. completion date: May 2011

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Biliary Tract Surgical Procedures
• Colectomy
• Esophagectomy
• Gastrectomy
• Hemorrhage
• Pancreaticoduodenectomy

Intervention

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)

Procedure:
• Standard of Care
Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss

Locations

Country	Name	City	State
India	Pfizer Investigational Site	Baroda	Gujarat
India	Pfizer Investigational Site	Surat	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post-operation, Day 1, Day 2 up to drain removal	No
Secondary	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.	Day 1 (End of surgery)	No
Secondary	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.	Baseline through Day 2 post-surgery	No
Secondary	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.	Baseline through Day 2 post-surgery	No
Secondary	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.	Up to Day 7 post-surgery	No
Secondary	Hemoglobin Levels		End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery	No
Secondary	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.	Day 7 post-surgery	Yes

External Links

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