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 | Completed

• 1 other identifier: 4-2009-0061
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Keywords

albumin; hydroxyethyl starch 130/0.4; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (3)

HA (priming)-HES (up to 15 ml/kg after CPB)

EXPERIMENTAL

Drug: Hydroxyethyl starch 130/0.4

HES (priming)-HES (up to 15 ml/kg after CPB)

ACTIVE COMPARATOR

Drug: Hydroxyethyl starch 130/0.4

HA (priming)-nonHES (only crystalloids after CPB)

ACTIVE COMPARATOR

Drug: Hydroxyethyl starch 130/0.4

Interventions

Hydroxyethyl starch 130/0.4 DRUG

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

HA (priming)-HES (up to 15 ml/kg after CPB)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Univ. dept. of Anesthesiology and pain medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Hydroxyethyl Starch Derivatives

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: June 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 19, 2012

Record last verified: 2012-07

Locations

KR (1)