Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture

NCT00824564 | Completed Phase 4 Results DMC

• 1 other identifier: B1461002
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft of femur.

Conditions

Femoral Fractures

Keywords

Tranexamic Acid; Blood Loss; Long Bone Fracture Surgery

Outcome Measures

Primary Outcomes (1)

• 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 7 post-surgery

Secondary Outcomes (6)

• Intra-operative Blood Loss

  Day 1 (End of surgery)

• Post-operative Blood Loss

  1, 4, 8 and 24 hours post-surgery

• Total Blood Loss Assessed by Gross' Formula

  Day 7 post-surgery

• Number of Participants Receiving Transfusions

  Up to day 7 post-surgery

• Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery

  Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery

Study Arms (2)

A

EXPERIMENTAL

Tranexamic Acid plus standard of care

Drug: Tranexamic Acid plus standard of care

B

OTHER

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

Procedure: Standard of care

Interventions

Tranexamic Acid plus 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 - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient undergoing surgery for fracture shaft of femur

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 or hematocrit \<24%)
• Patients with documented DVT or PE at screening or in past three months
• Patients having known hypersensitivity to tranexamic acid or any other constituent of the product
• 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 (1)

Pfizer Investigational Site

Coimbatore, Tamil Nadu, 641009, India

Location

Related Links

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

MeSH Terms

Conditions

Femoral Fractures; Hemorrhage

Interventions

Tranexamic Acid; Standard of Care

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; 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 data for hemoglobin levels was planned but not evaluated on the morning of Day 7 post-surgery.

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

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 16, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 28, 2011
• Results First Posted: June 28, 2011

Record last verified: 2011-06

Locations

IN (1)