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Sponsored by: |
Hamilton Health Sciences |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00182377 |
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 |
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Cardiac Surgery Cardiopulmonary Bypass |
Drug: Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch) |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Irene Cybulsky, MD | 905-777-8248 | cybulsky@hhsc.ca |
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 |
Principal Investigator: | Irene Cybulsky, MD | McMaster University |
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 |
patients undergoing cardiac surgery requiring cardiopulmonary bypass |
Hetastarch Plasma Substitutes |
Therapeutic Uses Hematologic Agents Blood Substitutes |
Hetastarch Plasma Substitutes Pharmacologic Actions |