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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01260818
First received: December 14, 2010
Last updated: November 30, 2011
Last verified: December 2010
History of Changes
  Purpose

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


Condition Intervention
Hip Replacement
Postoperative Hemorrhage
 Drug: Tranexamic Acid
Drug: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Blood loss as calculated from change in haematocrit [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intra-operative blood loss [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Postoperative blood loss [ Time Frame: postoperative 4 hours, 1 day, 2 days, 7days respectively ] [ Designated as safety issue: No ]
  • Hemoglobin levels [ Time Frame: postoperative 4 hours, 1 day, 2 days, 7days respectively ] [ Designated as safety issue: No ]
  • drainage volume [ Time Frame: postoperative 1 day, 2 days ] [ Designated as safety issue: No ]
  • Proportion of patients receiving transfusions [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Incidence of deep vein thrombosis postoperatively [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: control group Drug: normal saline
100ml saline is kept in wound for 2 hours before drainage is opened postoperatively

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260818

Locations
China, Guangdong
the First Affiliated Hospital of Guangzhou TCM University Recruiting
Guangzhou, Guangdong, China, 510405
Contact: Yong Li     86-02036591743     liyong1949@gmail.com    
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: the First Affiliated Hospital of Guangzhou TCM University
ClinicalTrials.gov Identifier: NCT01260818     History of Changes
Other Study ID Numbers: GZTCM-201001
Study First Received: December 14, 2010
Last Updated: November 30, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine:
Tranexamic Acid

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013