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

Postoperative Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01260818
• Other study ID #: GZTCM-201001
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2010
• Last updated: November 30, 2011
• Start date: December 2010

Study information

• Verified date: December 2010
• Source: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Replacement
• Postoperative Hemorrhage

Intervention

Drug:
• Tranexamic Acid
1 g Tranexamic Acid mixed with 100ml saline are kept in wound for 2 hours before drainage is opened postoperatively
• normal saline
100ml saline is kept in wound for 2 hours before drainage is opened postoperatively

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Guangzhou TCM University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss as calculated from change in haematocrit		7 days	No
Secondary	Intra-operative blood loss		1 day	No
Secondary	Postoperative blood loss		postoperative 4 hours, 1 day, 2 days, 7days respectively	No
Secondary	Hemoglobin levels		postoperative 4 hours, 1 day, 2 days, 7days respectively	No
Secondary	drainage volume		postoperative 1 day, 2 days	No
Secondary	Proportion of patients receiving transfusions		7 days	No
Secondary	Incidence of deep vein thrombosis postoperatively		7 days	Yes