At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 80 enrolled

Drug / intervention

Albumin +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02738190

NCT02738190Phase 4Completed

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Albumin vs. Plasma for PEdiAtric pRiming Trial

IRCCS Policlinico S. Donato·interventional·Posted Apr 14, 2016·Updated Aug 30, 2016

In Brief

A Phase 4 clinical trial evaluating Albumin and Fresh Frozen Plasma for Hemorrhage. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHemorrhage

CountriesItaly

Collaborators--

Timeline

Phase 4CompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartJan 2015

First PostedApr 2016

Primary CompletionMay 2016

TodayJul 2026

First PostedApr 14, 2016

Enrollment StartJan 1, 2015

Primary CompletionMay 1, 2016

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 10.2 years ago

Interventions

Albumindrug

Albumin 5% added to blood priming solution

Fresh Frozen Plasmabiological

Fresh Frozen Plasma added to blood priming solution