CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
method of returning residual CPB blood ( Hemobag®)device
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/NCT01435304
NCT01435304N/ACompleted

The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass

MaineHealth·interventional·Posted Sep 16, 2011·Updated Jun 6, 2018

In Brief

A clinical study evaluating method of returning residual CPB blood ( Hemobag®) for Blood Coagulation Disorders. Completed, enrolled 100 participants across 1 site.

Detailed Summary

This proposal is designed to mitigate hemodilution (blood diluted with an electrolyte solution) and loss of plasma proteins responsible for normal blood clotting as well as platelets at the completion of cardiopulmonary bypass (CPB). The Hemobag® system is a device qualified by the US Food and Drug Administration (FDA). Many cardiac centers, such as Englewood Hospital and Medical Center in Englewood NJ are using the Hemobag® system for Jehovah's witnesses and other patients who go to that center for bloodless cardiac surgery (cardiac surgery performed without the use of blood or blood products). The system is designed to filter excessive water from blood left in the heart lung machine (cardiopulmonary bypass) after it is separated from the patient during the performance of cardiac surgery. Consequently the likelihood of excessive post-operative bleeding and transfusion with allogeneic blood (blood bank blood from donors) is decreased.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 16, 2011
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.8 years ago

Interventions

method of returning residual CPB blood ( Hemobag®)device

The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB).