Reduction of blood loss in pediatric osteotomies around the hip - A randomized placebo-controlled trial with tranexamic acid

Phase 4

Recruiting

• Conditions: hip dislocation; hip dysplasia; 10023213

• Registration Number: NL-OMON51297
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

The patient population is composed of all patients aged 1-18 years, undergoing
a pelvic and/or femoral osteotomy (PFPO) at Erasmus MC-Sophia, for DDH,
secondary hip dysplasia, or other indications.

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Indication for PFPO
• Age 1-18 years

Exclusion Criteria

• Contra-indication for TXA (active thromboembolic disease, subarachnoidal
bleeding, severe renal insufficiency, history of convulsions, disseminated
intravascular coagulation)
• Active use of alternative (anti)fibrinolytics
• Diagnosed bleeding or coagulation disorder
• Medical history of thromboembolic complications
• Insufficient Dutch Language skills of parents/care-takers
• No informed consent
• Use of hormonal contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified