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Pentastarch Use in Cardiac Surgery
This study is currently recruiting participants.
Verified by McMaster University, September 2004
First Received: September 13, 2005   Last Updated: September 19, 2007   History of Changes
Sponsored by: Hamilton Health Sciences
Information provided by: McMaster University
ClinicalTrials.gov Identifier: NCT00182377
  Purpose

Patients undergoing cardiac surgery with cardiopulmonary bypass require significant fluid administration. Fluids are used routinely to replace blood lost during and after surgery. Significant amounts of fluid are also used to prime the tubing and components of the cardiopulmonary bypass pump before and during its use. The use of Pentaspan - a synthetic pentastarch - was started because of the restriction of use for blood and blood products, particularly albumin. Pentaspan is usually used after surgery in the Intensive Care Unit (ICU). The impact of the use of pentastarch on coagulation, fluid balance and bleeding are very limited. This study will methodically evaluate the impact of using increasingly greater amounts of pentastarch during surgery on an open heart surgery patient's recovery in particular - is there more bleeding, does his/her blood clot as well, and how much fluid overall is used and excreted?


Condition Intervention
Cardiac Surgery
Cardiopulmonary Bypass
Drug: Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)

MedlinePlus related topics: Heart Surgery Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Randomized, Prospective, Blinded Clinical Trial to Evaluate the Efficacy and Safety of Pentastarch Use in Patients Undergoing Coronary Artery Bypass Surgery or Valve Replacement Surgery Using Cardiopulmonary Bypass Circuits

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • transfusion requirements
  • fluid balance

Secondary Outcome Measures:
  • postoperative bleeding
  • mediastinal drainage
  • coagulation parameters
  • respiratory status

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing either coronary artery bypass surgery or valve surgery requiring the use of cardiopulmonary bypass circuit

Exclusion Criteria:

  • Emergency surgery
  • Regurgitant valve pathology
  • Redo surgery
  • Significant left ventricular (LV) dysfunction
  • Significant renal insufficiency
  • Anticipation of associated procedure - eg carotid endarterectomy
  • Ongoing sepsis or endocarditis
  • Received aspirin (ASA) or Plavix within 96 hours of surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182377

Contacts
Contact: Irene Cybulsky, MD 905-777-8248 cybulsky@hhsc.ca

Locations
Canada, Ontario
Hamilton Health Sciences - General Division Recruiting
Hamilton, Ontario, Canada, lL8L 2X2
Contact: Mary-Helen Blackall     905 -527-4322 ext 44228     blackall @hhsc.ca    
Sponsors and Collaborators
Hamilton Health Sciences
Investigators
Principal Investigator: Irene Cybulsky, MD McMaster University
  More Information

No publications provided

Study ID Numbers: 02-183
Study First Received: September 13, 2005
Last Updated: September 19, 2007
ClinicalTrials.gov Identifier: NCT00182377     History of Changes
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
patients undergoing cardiac surgery requiring cardiopulmonary bypass

Study placed in the following topic categories:
Hetastarch
Plasma Substitutes

Additional relevant MeSH terms:
Therapeutic Uses
Hematologic Agents
Blood Substitutes
Hetastarch
Plasma Substitutes
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009