Phase 4
N=82
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Femoral Fractures
Bottom Line
View on ClinicalTrials.gov: NCT00824564 ↗Enrolled (actual)
82
Serious AEs
6.2%
Results posted
Jun 2011
Primary outcome: Primary: Total Blood Loss — 370.7; 426.2 Milliliters (mL) — p=0.348
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic Acid plus standard of care (Drug); Standard of care (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Blood Loss |
370.7; 426.2 | 0.348 |
| SECONDARY Intra-operative Blood Loss |
316.2; 292.2 | 0.466 |
| SECONDARY Post-operative Blood Loss |
0.2; 9.5; 0.6; 7.4; 0.7; 7.5 | 0.109 |
| SECONDARY Total Blood Loss Assessed by Gross' Formula |
823.2; 798.0 | 0.849 |
| SECONDARY Number of Participants Receiving Transfusions |
5; 6 | 0.714 |
| SECONDARY 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 |
13.1; 12.9; -1.7; -2.0; -1.8; -1.9 | 0.208 |
| SECONDARY Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery |
3; 0 | 0.241 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00824564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.