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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00824564

Purpose

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.

Condition	Intervention	Phase
Femoral Fractures	Drug: Tranexamic Acid plus standard of care Procedure: Standard of care	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Fractures Surgery

Drug Information available for: Tranexamic acid

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Total blood loss (intra-operative + post-operative) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intra-operative blood loss [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Postoperative blood loss [ Time Frame: 1, 4, 8, 24 hours ] [ Designated as safety issue: No ]
Total blood loss as assessed by Gross' formula [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Proportion of patients receiving transfusions [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Hemoglobin levels [ Time Frame: at the end of the operation, one hour postoperatively and on the mornings of the first, second, four ] [ Designated as safety issue: No ]
Incidence of deep vein thrombosis postoperatively [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	94
Study Start Date:	April 2009
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Tranexamic Acid plus standard of care	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)
B 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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824564

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

India, Tamil Nadu
Pfizer Investigational Site	Recruiting
Coimbatore, Tamil Nadu, India, 641009

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1461002
Study First Received:	January 14, 2009
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00824564 History of Changes
Health Authority:	India: Institutional Review Board

Keywords provided by Pfizer:

Tranexamic Acid Blood Loss Long Bone Fracture Surgery

Study placed in the following topic categories:

Fibrin Modulating Agents
Antiplasmin
Femoral Fractures
Antifibrinolytic Agents
Fractures, Bone
Wounds and Injuries

Anesthetics
Disorders of Environmental Origin
Tranexamic Acid
Leg Injuries
Hemorrhage
Hemostatics

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Coagulants
Fractures, Bone
Hematologic Agents
Wounds and Injuries
Disorders of Environmental Origin
Tranexamic Acid

Pharmacologic Actions
Hemostatics
Femoral Fractures
Fibrin Modulating Agents
Antifibrinolytic Agents
Therapeutic Uses
Leg Injuries

ClinicalTrials.gov processed this record on September 04, 2009