Comparison of 6% Hydroxyethyl Starch 130/0.4 With 5% Albumin as Priming Solution for Cardiopulmonary Bypass

NCT ID: NCT00978588

Last Updated: 2012-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-08-31

Brief Summary

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Comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for cardiopulmonary bypass

Detailed Description

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Conditions

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Mitral Valvular Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HES 130/0.4

Group Type EXPERIMENTAL

6% hydroxyethyl starch 130/0.4 and 5% albumin

Intervention Type DRUG

Injection of 6% hydroxyethyl starch 130/0.4 and 5% albumin as priming solution for cardiopulmonary bypass

5% albumin

Group Type ACTIVE_COMPARATOR

6% hydroxyethyl starch 130/0.4 and 5% albumin

Intervention Type DRUG

Injection of 6% hydroxyethyl starch 130/0.4 and 5% albumin as priming solution for cardiopulmonary bypass

Interventions

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6% hydroxyethyl starch 130/0.4 and 5% albumin

Injection of 6% hydroxyethyl starch 130/0.4 and 5% albumin as priming solution for cardiopulmonary bypass

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mitral valvular heart disease

Exclusion Criteria

* Status of Infection
* Re-operation
* Liver failure
* Renal disease
* Administration of steroid
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young Lan Kwak, M.D.,PhD,

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Other Identifiers

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4-2007-0429

Identifier Type: -

Identifier Source: org_study_id

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