ZEro_PLASma Trial in small infants undergoing cardiac surgery

Phase 1

• Conditions: Congenital heart disease; MedDRA version: 20.0Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-004068-74-IT
• Lead Sponsor: I.R.C.C.S. POLICLINICO SAN DONATO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-16
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- Newborns and infants weighin less than 10 kg undergoing cardiac surgery with extracorporeal circulation
- Informed consent signed by parents or legal tutor
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

- Emergency surgery
- congenital coagulopathy
- participation to other clinical trials

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Avoidance of fresh frozen plasma employment in newborns and infants weighing less than 10 kg undergoing cardiac surgery with extracorporeal circulation;Secondary Objective: Non-inferiority of the zero-plasma strategy in terms of postoperative bleeding (absolute valute, ml/kg), incidence of severe bleeding and surgical re-explorations due to bleeding in the first 12, 24 and 48 postoperative hours;Primary end point(s): Avoidance of fresh frozen plasma in the newborn and infants weighing less than 10 kg undergoing cardiac surgery with extracorporeal circulation;Timepoint(s) of evaluation of this end point: 48 postoperative hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Non-inferiority of the zero-plasma strategy in terms of postoperative bleeding (absolute value, ml/kg), incidence of severe bleeding and surgical re-explorations due to bleeding in the first 12, 24 and 48 postoperative hours;Timepoint(s) of evaluation of this end point: 12, 24 and 48 postoperative hours