Research to study the difference in coagulation between two differentkinds of blood plasma products in heart surgery in children.

Phase 1

• Conditions: coagulation in pediatric cardiac surgery; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2021-000444-22-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-22
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

·Informed consent
·Cardiac surgery with the use of CPB
·Group 1A and Group 2A children < 1 year old
·Group 1B and Group 2B Glenn / Fontan surgery

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

No informed consent
·Cardiac surgery without the use of CPB
·Preoperative known coagulation disorders
·Known allergy for FFP or Omniplasma

Study & Design

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