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

Study Overview
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Brief Summary
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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
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Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Intervention / Treatment
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* Drug: Hydroxyethyl starch 130/0.4
* Drug: Hydroxyethyl starch 130/0.4
* Drug: Hydroxyethyl starch 130/0.4


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HA (priming)-HES (up to 15 ml/kg after CPB)<br> | Drug: Hydroxyethyl starch 130/0.4<br>* Hydroxyethyl starch 130/0.4 as a priming of cardiopulmonary bypass circuit and/or as a fluid after cardiopulmonary bypass<br>|
| Active Comparator: HES (priming)-HES (up to 15 ml/kg after CPB)<br> | Drug: Hydroxyethyl starch 130/0.4<br>* Hydroxyethyl starch 130/0.4 as a priming of cardiopulmonary bypass circuit and/or as a fluid after cardiopulmonary bypass<br>|
| Active Comparator: HA (priming)-nonHES (only crystalloids after CPB)<br> | Drug: Hydroxyethyl starch 130/0.4<br>* Hydroxyethyl starch 130/0.4 as a priming of cardiopulmonary bypass circuit and/or as a fluid after cardiopulmonary bypass<br>|

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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albumin, hydroxyethyl starch 130/0.4, cardiopulmonary bypass