Reduction of blood loss in pediatric surgical procedures around the hip - A trial with tranexamic acid

Phase 4

Recruiting

• Conditions: Slipped capital femoral epiphysis (SCFE); Legg-Calvé-Perthes Disease (LCPD); Neuromuscular conditions; Secondary hip dysplasia; Developmental dysplasia of the hip (DDH)

• Registration Number: 2024-516324-34-01
• Lead Sponsor: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Brief Summary

To evaluate (reduction of) intraoperative blood-loss with and without pre-operative TXA administration, in children undergoing a proximal femoral and/or pelvic osteotomy (PFPO).

Primary research question:

Is pre-operative TXA administration associated with reduced intraoperative blood loss, compared to placebo, in children undergoing a proximal femoral and/or pelvic osteotomy for DDH or other indications?

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

Proximal femoral and/or pelvic osteotomy/ies

1-18 years old

Any indication for surgery

Performed at our institution

Exclusion Criteria

Contraindications for TXA

Active use of alternative (anti)fibrinolytics

Diagnosed bleeding or coagulation disorder

Medical history of thromboembolic complications

Use of hormonal contraception

Insufficient Dutch language skills of the patient and/or caretakers

No informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimated intraoperative blood loss (ml/kg)		Estimated intraoperative blood loss (ml/kg)

Secondary Outcome Measures

Name	Time	Method
Baseline demographic data		Baseline demographic data
Indication for surgery		Indication for surgery
Prior surgery at same site		Prior surgery at same site
Treatment characteristics		Treatment characteristics
Operative time		Operative time
Eventual additional antifibrinolytic agents administered during surgery (including TXA)		Eventual additional antifibrinolytic agents administered during surgery (including TXA)
Blood transfusions		Blood transfusions
Pre- and postoperative blood values, including Hb		Pre- and postoperative blood values, including Hb
Complications		Complications
Duration of hospital stay		Duration of hospital stay

Trial Locations

Locations (1)

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC); 🇳🇱 Rotterdam, Netherlands

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

🇳🇱Rotterdam, Netherlands

J.J. Tolk

Site contact

+31107036657

kinderorthopedie@erasmusmc.nl