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

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

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 Overview

• Status: Unknown
• Conditions: Postoperative Hemorrhage; Hip Replacement
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510405
      • Recruiting
      • the First Affiliated Hospital of Guangzhou TCM University
      • Contact: Yong Li; Phone Number: 86-02036591743; Email: liyong1949@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group	Drug: normal saline; 100ml saline is kept in wound for 2 hours before drainage is opened postoperatively
Experimental: Tranexamic Acid	Drug: Tranexamic Acid; 1 g Tranexamic Acid mixed with 100ml saline are kept in wound for 2 hours before drainage is opened postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood loss as calculated from change in haematocrit	7 days

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Yong Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: December 14, 2010
• First Posted (Estimate): December 15, 2010

Study Record Updates

• Last Update Posted (Estimate): December 1, 2011
• Last Update Submitted That Met QC Criteria: November 30, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Tranexamic Acid
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: GZTCM-201001