The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01622946
First received: June 14, 2012
Last updated: June 18, 2012
Last verified: April 2012
  Purpose

The effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the suction drain following a total hip replacement


Condition Intervention Phase
Total Hip Arthroplasty
Postoperative Blood Loss
Drug: Tranexamic Acid
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach. A Prospective, Double Blind, Placebo-controlled Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • postoperative blood loss in patients undergoing primary total hip arthroplasty [ Time Frame: Haemoglobin levels, on which the postopererative blood loss is calculated, is measured preoperative and on day 1 and 4 postoperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: April 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Placebo
The patients who receive placebo form the control group. The results can be compared with the results of the patients who did receive TXA
Drug: placebo
The patients will receive 3g topical TXA for 15 minutes or 2 hours after THA. 33% of the patients will receive 3g of TXA trough a suction drain for 15 minutes after total hip arthroplasty, then the suction drain is opened. 33% will receive the same amount of TXA but the suction drain will only be opened 2 hours after application. The other patients will receive a placebo in the same manner
Placebo Comparator: Tranexamic acid
The patients will receive 3g topical TXA for 15 minutes or 2 hours after THA. 33% of the patients will receive 3g of TXA trough a suction drain for 15 minutes after total hip arthroplasty, then the suction drain is opened. 33% will receive the same amount of TXA but the suction drain will only be opened 2 hours after application. The other patients will receive a placebo in the same manner
Drug: Tranexamic Acid
3g of tranexamic acid is topically applied after THA. The drugs is left for 15 minutes or 2 hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who will receive a unilateral total hip arthroplasty

Exclusion Criteria:

  • coagulopathy
  • allergy to tranexamic acid
  • preoperative anemia (a hemoglobin value of < 11g/dL in females and < 12g/dL in males)
  • fibrinolytic disorders
  • a history of arterial or venous thromboembolic disease
  • pregnancy
  • breastfeeding
  • major comorbidities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622946

Locations
Belgium
UZ Pellenberg Recruiting
Pellenberg, Belgium
Contact: Colette Van Elst       colette.vanelst@student.kuleuven.be   
Contact: Kristoff Corten         
Principal Investigator: Colette Van Elst         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01622946     History of Changes
Other Study ID Numbers: 2010-024410-59
Study First Received: June 14, 2012
Last Updated: June 18, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
total hip arthroplasty
tranexamic acid
postoperative blood loss

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 September 16, 2014