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

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ClinicalTrials.gov Identifier: NCT00978588
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for cardiopulmonary bypass

Condition or disease Intervention/treatment
Mitral Valvular Heart Disease Drug: 6% hydroxyethyl starch 130/0.4 and 5% albumin

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2008
Primary Completion Date : December 2008
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: HES 130/0.4 Drug: 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
Active Comparator: 5% albumin Drug: 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


Outcome Measures

Primary Outcome Measures :
  1. the pure effect of priming solutions [ Time Frame: after CPB ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mitral valvular heart disease

Exclusion Criteria:

  • Status of Infection
  • Re-operation
  • Liver failure
  • Renal disease
  • Administration of steroid
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978588


Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Young Lan Kwak, M.D.,PhD, Severance Hospital
More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT00978588     History of Changes
Other Study ID Numbers: 4-2007-0429
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes