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ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery

NCT04434001 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-11-03

No results posted yet for this study

Summary

In pediatric patients (newborns and infants weighing less than 10 kg) undergoing cardiac surgery with extracorporeal circulation postoperative bleeding represents a known complication with a significant impact on outcome. Fresh frozen plasma (FFP) for bleeding management is associated, particularly in this kind of patients, to volume overload and a significative increase of Transfusion Related Acute Lung Injury (TRALI), further worsening the postoperative outcome. In the adult patient FFP employment could be almost completely canceled by administration of concentrated hemostatic components - the fibrinogen concentrate and prothrombin complex concentrate (PCC). We designed this phase II pilot study to establish whether an analogous strategy, modified accordingly to pediatric physiology, could be safely and successfully applied in newborns and infants.

Conditions

  • Bleeding
  • Cardiac Defect
  • Surgery--Complications
  • Fibrinogenopenia; Acquired
  • Transfusion-Related Acute Lung Injury
  • Transfusion-Associated Circulatory Overload
  • Congenital Heart Disease

Interventions

DRUG

Fibrinogen Concentrate Human

Treatment of acquired postoperatively fibrinogen deficiency as assessed by ROTEM FIBTEM test.

DRUG

Prothrombin Complex Concentrate

Treatment of acquired postoperatively thrombin generation deficiency as assessed by ROTEM EXTEM test.

BIOLOGICAL

Fresh Frozen Plasma

Treatment of acquired postoperative coagulopathy as assessed by ROTEM FIBTEM and INTEM tests.

Sponsors & Collaborators

  • IRCCS Policlinico S. Donato

    lead OTHER

Principal Investigators

  • Marco Ranucci, MD · IRCCS Policlinico S. Donato

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-27
Primary Completion
2021-05-31
Completion
2021-06-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04434001 on ClinicalTrials.gov