Hip Replacement, Postoperative Hemorrhage
Conditions
Keywords
Tranexamic Acid
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
Interventions
DRUGTranexamic Acid
1 g Tranexamic Acid mixed with 100ml saline are kept in wound for 2 hours before drainage is opened postoperatively
DRUGnormal saline
100ml saline is kept in wound for 2 hours before drainage is opened postoperatively
Sponsors
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood loss as calculated from change in haematocrit | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed