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

July 18, 2012 updated by: Yonsei University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Yonsei Univ. dept. of Anesthesiology and pain medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who have uncontrolled medical problems, life-threatening cardiac disease, complex cardiac surgery, or emergency operation

Exclusion Criteria:

  • patients who had received warfarin, heparin, acetylsalicylic acid, or antiplatelet drug within 5 days before surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HA (priming)-HES (up to 15 ml/kg after CPB)
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
Active Comparator: HES (priming)-HES (up to 15 ml/kg after CPB)
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
Active Comparator: HA (priming)-nonHES (only crystalloids after CPB)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of 6% hydroxyethyl starch 130/0.4 as a priming solution on coagulation and blood loss following complex heart valve surgery: a comparison with 5% albumin
Time Frame: upto 24hours after cardiopulmonary bypass
The purspose 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. Rotation thromboelastography (ROTEM) was performed before and 24 h after CPB. Hemoglobin, platelet count and transfusion requirement were assessed for 24 h postoperatively.
upto 24hours after cardiopulmonary bypass

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

July 17, 2012

First Posted (Estimate)

July 18, 2012

Study Record Updates

Last Update Posted (Estimate)

July 19, 2012

Last Update Submitted That Met QC Criteria

July 18, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2009-0061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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