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Albumin vs. Plasma for PEdiAtric pRiming Trial

NCT02738190 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-08-30

No results posted yet for this study

Summary

This is a randomized controlled trial that compares two different priming composition (albumin vs. fresh frozen plasma) for extracorporeal circulation of pediatric patients under 10 kg of weight. The two approaches are both employed at the moment but there is actually no evidence on the superiority of one over the other. This study is aimed to test the hypothesis that Albumin is superior to fresh frozen plasma in terms of minor bleeding and transfusional requirements.

Conditions

Interventions

DRUG

Albumin

Albumin 5% added to blood priming solution

BIOLOGICAL

Fresh Frozen Plasma

Fresh Frozen Plasma added to blood priming solution

Sponsors & Collaborators

  • IRCCS Policlinico S. Donato

    lead OTHER

Principal Investigators

  • Marco Ranucci, MD, FESC · IRCCS Policlinico S. Donato

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT02738190 on ClinicalTrials.gov