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

NCT01622946 | Completed Phase 4

• 1 other identifier: 2010-024410-59
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Total Hip Arthroplasty; Postoperative Blood Loss

Keywords

total hip arthroplasty; tranexamic acid; postoperative blood loss

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo

ACTIVE COMPARATOR

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

Tranexamic acid

PLACEBO COMPARATOR

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

Interventions

Tranexamic Acid DRUG

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

Tranexamic acid

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

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who will receive a unilateral total hip arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Pellenberg

Pellenberg, Belgium

Location

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 19, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

BE (1)