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

NCT00827931 | Completed Phase 4 Results DMC

• 1 other identifier: B1461001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

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.

Conditions

Biliary Tract Surgical Procedures; Pancreaticoduodenectomy; Esophagectomy; Colectomy; Gastrectomy

Keywords

tranexamic acid; major abdominal surgery; blood loss

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Intra-operative Blood Loss

  Day 1 (End of surgery)

• Total Blood Loss

  Baseline through Day 2 post-surgery

• Total Blood Loss as Assessed by the Gross' Formula

  Baseline through Day 2 post-surgery

• Percentage of Participants Receiving Transfusions

  Up to Day 7 post-surgery

• Hemoglobin Levels

  End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery

Study Arms (2)

A

EXPERIMENTAL

end of the operation and on the mornings of the first, second, fourth and seventh postoperative days.

Drug: Tranexamic acid + Standard of Care

B

OTHER

Standard of Care

Procedure: Standard of Care

Interventions

Tranexamic acid + Standard of Care DRUG

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)

A

Standard of Care PROCEDURE

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing major abdominal surgery (Biliary strictures, Pancreatico-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy, Gastrectomy, Other major abdominal surgeries with similar expected blood loss)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Surat, Gujarat, 395 001, India

Location

Pfizer Investigational Site

Vadodara, Gujarat, 390 001, India

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid; Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 23, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 26, 2012
• Results First Posted: April 26, 2012

Record last verified: 2012-04

Locations

IN (2)