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

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ClinicalTrials.gov Identifier: NCT01622946
Recruitment Status : Unknown
Verified April 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : June 19, 2012
Last Update Posted : June 19, 2012
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
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 or disease Intervention/treatment Phase
Total Hip Arthroplasty Postoperative Blood Loss Drug: Tranexamic Acid Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : April 2012
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01622946     History of Changes
Other Study ID Numbers: 2010-024410-59
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: April 2012

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
Hemostatics
Coagulants