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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Coimbatore, Tamil Nadu, 641009 India
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Femoral Fractures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patient undergoing surgery for fracture shaft of femur

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- 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

NCT00824564
Pfizer
Completed
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture

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Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Femoral Fractures
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
June 2010
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00824564
B1461002
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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