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

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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01622946
Enrollment
80
Registered
2012-06-19
Start date
2012-04-30
Completion date
2020-04-30
Last updated
2020-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Blood Loss, Total Hip Arthroplasty

Keywords

total hip arthroplasty, tranexamic acid, postoperative blood loss

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

Interventions

DRUGTranexamic Acid

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

DRUGplacebo

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

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
postoperative blood loss in patients undergoing primary total hip arthroplastyHaemoglobin levels, on which the postopererative blood loss is calculated, is measured preoperative and on day 1 and 4 postoperative

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026