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

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT01622946

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty Postoperative Blood Loss	Drug: Tranexamic Acid Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual 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.

Actual Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Apr 1, 2020

Actual Study Completion Date :

Apr 1, 2020

Arms and Interventions

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

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

Drug: Tranexamic Acid

3g of tranexamic acid is topically applied after THA. The drugs is left for 15 minutes or 2 hours

Outcome Measures

Primary Outcome Measures

postoperative blood loss in patients undergoing primary total hip arthroplasty [Haemoglobin levels, on which the postopererative blood loss is calculated, is measured preoperative and on day 1 and 4 postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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