Text Size

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
History of Changes
  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:

Drug Information available for: Hetastarch
U.S. FDA Resources

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

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
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

No publications provided

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
Hetastarch
Plasma Substitutes
 Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013