ZEro_PLASma Trial in small infants undergoing cardiac surgery

ZEro_PLASma Trial in small infants undergoing cardiac surgery - ZEPLAST-PED

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004068-74-IT

Enrollment

Registered

2020-12-16

Start date

2019-09-26

Completion date

Unknown

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital heart disease MedDRA version: 20.0 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: HAEMOCOMPLETTAN Product Name: Haemocomplettan P Product Code: [Haemocomplettan P] Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: FIBRINOGENO UMANO LIOFILIZZATO

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - Emergency surgery - congenital coagulopathy - participation to other clinical trials

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactLaboratorio di Emostasi e Coagulazi

I.R.C.C.S. POLICLINICO SAN DONATO

ekaterina.baryshnikova@grupposandonato.it0252774546

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026