CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 61 enrolled
Drug / intervention
HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L) +1 moredrug
Likely dose
HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)from 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.

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NCT00860405Phase 4Completed
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Efficacy and Safety of 6 % Hydroxyethyl Starch 130/0.4 (Voluven®) vs. 5% HSA in Volume Replacement Therapy During Elective Open-heart Surgery in Paediatric Patients

Fresenius Kabi·interventional·Posted Mar 12, 2009·Updated Nov 2, 2011

In Brief

A Phase 4 clinical trial evaluating HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L) and Human serum albumin (HSA 50g/L) for Cardiac Surgery and Cardiopulmonary Bypass. Completed, enrolled 61 participants across 2 sites in 2 countries.

Detailed Summary

This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Surgery, Cardiopulmonary Bypass
CountriesAustria, Belgium
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2009
Enrollment StartMar 1, 2009
Primary CompletionAug 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.3 years ago

Interventions

HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)drug

Study medication will be given as part of the priming of the ECC and for plasma volume replacement after start of ECC up to the maximum dosage of 50 mL/kg body weight/day.

Human serum albumin (HSA 50g/L)drug

Human serum albumin (HSA 50g/L)