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Pentastarch Use in Cardiac Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2004 by McMaster University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00182377
First Posted: September 16, 2005
Last Update Posted: September 20, 2007
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:
McMaster University
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

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:

  • 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
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): 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 Corporation
Investigators
Principal Investigator: Irene Cybulsky, MD McMaster University
  More Information

ClinicalTrials.gov Identifier: NCT00182377     History of Changes
Other Study ID Numbers: 02-183
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: September 20, 2007
Last Verified: September 2004

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

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes