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

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

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Key information

Conditions

Total Hip Arthroplasty Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Blood Loss Postoperative Complications Postoperative Hemorrhage

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UZ Pellenberg

Pellenberg, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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

Placebo

Drug

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study 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.

Important dates

Study start: 2012
Primary completion: 2020
Study completion: 2020
First posted: Jun 19, 2012
Registry last updated: Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed