NCT01260818
Unknown
Not Applicable
Prospective Randomized Trial Comparing Topical Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss Following Primary Total Hip Arthroplasty Surgery
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine1 site in 1 country100 target enrollmentStarted: December 2010Last updated:
Overview
- Phase
- Not Applicable
- Sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Blood loss as calculated from change in haematocrit
Overview
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 intravenously in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of topical use of tranexamic acid in reduction of blood loss and transfusions for total hip arthroplasty
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient who are to undergo elective total hip arthroplasty.
- •Must be primary arthroplasty.
- •Must be single-side arthroplasty.
- •Must be older than 18 years.
Exclusion Criteria
- •Cemented arthroplasty.
- •Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia .
- •Patients with known coagulopathy (APTT or PT outside normal range pre-operatively).
- •Patients who have a past medical history of thrombi-embolism at any time.
- •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 \[New York Heart Association Class III or IV\] 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.
- •Jehovah's Witnesses, or any other group of patients with ethical objections to receiving blood products.
Arms & Interventions
Tranexamic Acid
Experimental
Intervention: Tranexamic Acid (Drug)
control group
Placebo Comparator
Intervention: normal saline (Drug)
Outcomes
Primary Outcomes
Blood loss as calculated from change in haematocrit
Time Frame: 7 days
Secondary Outcomes
- Intra-operative blood loss(1 day)
- Postoperative blood loss(postoperative 4 hours, 1 day, 2 days, 7days respectively)
- Hemoglobin levels(postoperative 4 hours, 1 day, 2 days, 7days respectively)
- drainage volume(postoperative 1 day, 2 days)
- Proportion of patients receiving transfusions(7 days)
- Incidence of deep vein thrombosis postoperatively(7 days)
Investigators
Study Sites (1)
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