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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:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT00978588
First received: September 16, 2009
Last updated: February 2, 2012
Last verified: February 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: September 16, 2009
Last Updated: February 2, 2012
Health Authority: South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on December 08, 2016