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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00978588
First Posted: September 17, 2009
Last Update Posted: February 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
Comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for cardiopulmonary bypass

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

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

Enrollment: 36
Study Start Date: February 2008
Study Completion Date: August 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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 Submitted: September 16, 2009
First Posted: September 17, 2009
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