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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 4

Conditions: Postoperative Blood Loss; Total Hip Arthroplasty

Treatments: Drug: placebo; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01622946

2010-024410-59

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Placebo

Active Comparator group

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

Treatment:

Drug: placebo

Tranexamic acid

Placebo Comparator group

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

Treatment:

Drug: Tranexamic Acid