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

• ClinicalTrials.gov Identifier: NCT00824564
• Recruitment Status: Completed
• First Posted: January 16, 2009
• Results First Posted: June 28, 2011
• Last Update Posted: June 28, 2011
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: January 14, 2009
• First Posted Date: January 16, 2009
• Results First Submitted Date: June 6, 2011
• Results First Posted Date: June 28, 2011
• Last Update Posted Date: June 28, 2011
• Study Start Date: April 2009
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 6, 2011)

Total Blood Loss [ Time Frame: Baseline through Day 7 post-surgery ]

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.

• Original Primary Outcome Measures (submitted: January 14, 2009): Total blood loss (intra-operative + post-operative) [ Time Frame: 7 days ]

Current Secondary Outcome Measures (submitted: June 6, 2011)

• Intra-operative Blood Loss [ Time Frame: Day 1 (End of surgery) ]
  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.
• Post-operative Blood Loss [ Time Frame: 1, 4, 8 and 24 hours post-surgery ]
  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.
• Total Blood Loss Assessed by Gross' Formula [ Time Frame: Day 7 post-surgery ]
  Gross's formula for estimating total blood loss: Estimated blood volume*[(Hematocrit initial - Hematocrit final)/ Hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.
• Number of Participants Receiving Transfusions [ Time Frame: Up to day 7 post-surgery ]
  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 haematocrit value of 24 percent.
• 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 [ Time Frame: Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery ]
• Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery [ Time Frame: Day 5 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.

Original Secondary Outcome Measures (submitted: January 14, 2009)

• Intra-operative Blood Loss [ Time Frame: 1 day ]
• Postoperative blood loss [ Time Frame: 1, 4, 8, 24 hours ]
• Total blood loss as assessed by Gross' formula [ Time Frame: 7 days ]
• Proportion of patients receiving transfusions [ Time Frame: 7 days ]
• Hemoglobin levels [ Time Frame: at the end of the operation, one hour postoperatively and on the mornings of the first, second, four ]
• Incidence of deep vein thrombosis postoperatively [ Time Frame: 7 days ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
• Official Title: Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Femoral Fractures

Intervention

• Drug: Tranexamic Acid plus 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

Study Arms

• Experimental: A
  Tranexamic Acid plus standard of care
  Intervention: Drug: Tranexamic Acid plus standard of care
• B
  Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss.
  Intervention: Procedure: Standard of care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 14, 2010): 82
• Original Estimated Enrollment (submitted: January 14, 2009): 94
• Actual Study Completion Date: June 2010
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient undergoing surgery for fracture shaft of femur

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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT00824564
• Other Study ID Numbers: B1461002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2011