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

Primary Purpose

Total Hip Arthroplasty, Postoperative Blood Loss

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Tranexamic Acid
placebo
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Total Hip Arthroplasty focused on measuring total hip arthroplasty, tranexamic acid, postoperative blood loss

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ Pellenberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Placebo

Tranexamic acid

Arm Description

The patients who receive placebo form the control group. The results can be compared with the results of the patients who did receive TXA

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

Outcomes

Primary Outcome Measures

postoperative blood loss in patients undergoing primary total hip arthroplasty

Secondary Outcome Measures

Full Information

First Posted
June 14, 2012
Last Updated
November 4, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01622946
Brief Title
The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach
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 Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
April 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Hip Arthroplasty, Postoperative Blood Loss
Keywords
total hip arthroplasty, tranexamic acid, postoperative blood loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
The patients who receive placebo form the control group. The results can be compared with the results of the patients who did receive TXA
Arm Title
Tranexamic acid
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
3g of tranexamic acid is topically applied after THA. The drugs is left for 15 minutes or 2 hours
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UZ Pellenberg
City
Pellenberg
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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