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A Comparison Between 5% Albumin and 6% Hydroxyethyl Starch 130/0.4 in Priming Solution for Cardiopulmonary Bypass and Post-bypass Maintenance Fluid in High-risk Patients

NCT01644084 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2012-07-19

No results posted yet for this study

Summary

It is advantageous to use 5% human albumin (HA) in patients undergoing cardiopulmonary bypass (CPB), because preexposure of the synthetic surfaces of the CPB circuit to albumin decreases coagulopathy, platelet aggregation, immune responses. However the use of albumin is limited, because it is expensive and can rarely cause infection.

Hydroxyethyl starch (HES) decreases clot strength and prolong clot formation. A recently developed 6% HES 130/0.4 is known to have fewer effects on hemostasis. However Schramlo AA et al. reported that short time infusion of HES 130/0.4 after cardiac surgery produced impairment in fibrin formation and clot strength in thromboelastometry tracings.

Coagulopathy is directly related to bleeding and massive postoperative bleeding increases the risk of reoperation. Therefore it is important to avoid administration of fluids that can inhibit homeostasis after CPB.

The purpose of this study is to investigate the effect of 6% HES 130/0.4 as a component of priming solution on coagulation compared to 5% HA.

Conditions

  • Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Interventions

DRUG

Hydroxyethyl starch 130/0.4

Hydroxyethyl starch 130/0.4 as a priming of cardiopulmonary bypass circuit and/or as a fluid after cardiopulmonary bypass

DRUG

Hydroxyethyl starch 130/0.4

Hydroxyethyl starch 130/0.4 as a priming of cardiopulmonary bypass circuit and/or as a fluid after cardiopulmonary bypass

DRUG

Hydroxyethyl starch 130/0.4

Hydroxyethyl starch 130/0.4 as a priming of cardiopulmonary bypass circuit and/or as a fluid after cardiopulmonary bypass

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-01-31
Completion
2011-04-30

Countries

  • South Korea

Study Locations

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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 NCT01644084 on ClinicalTrials.gov