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

Not Applicable

Completed

• Conditions: Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
• Interventions: Drug: Hydroxyethyl starch 130/0.4

• Registration Number: NCT01644084
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2011-01
• Study Completion: 2011-04
• Status Verified: 2012-07
• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-18
• Last Update Submitted: 2012-07-18
• Last Update Posted: 2012-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HA (priming)-HES (up to 15 ml/kg after CPB)	Hydroxyethyl starch 130/0.4	-
HES (priming)-HES (up to 15 ml/kg after CPB)	Hydroxyethyl starch 130/0.4	-
HA (priming)-nonHES (only crystalloids after CPB)	Hydroxyethyl starch 130/0.4	-

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Yonsei Univ. dept. of Anesthesiology and pain medicine; 🇰🇷 Seoul, Korea, Republic of