Topical Application of Tranexamic Acid Reduces Postoperative Blood Loss in Total Hip Arthroplasty

Not Applicable

• Conditions: Hip Replacement; Postoperative Hemorrhage
• Interventions: Drug: normal saline; Drug: Tranexamic Acid

• Registration Number: NCT01260818
• Lead Sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study Start: 2010-12
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Last Update Submitted: 2011-11-30
• Primary Completion: 2011-12
• Last Update Posted: 2011-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	normal saline	-
Tranexamic Acid	Tranexamic Acid	-

Primary Outcome Measures

Name	Time	Method
Blood loss as calculated from change in haematocrit	7 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

the First Affiliated Hospital of Guangzhou TCM University; 🇨🇳 Guangzhou, Guangdong, China