Recruiting

Pentaspan

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT00182377

Conditions

Cardiac Surgery

Cardiopulmonary Bypass

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)

Study Details

Brief summary:

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?

Conditions

Cardiac Surgery

Cardiopulmonary Bypass

Study ID

NCT00182377

Status verified date

Sep, 2004

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)

Primary outcome measure

  • transfusion requirements [ Time Frame: undefined ]
  • fluid balance [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Irene Cybulsky, MD

905-777-8248cybulsky@hhsc.ca

Locations

Hamilton Health Sciences - General Division

Recruiting

Hamilton, Ontario, Canada, lL8L 2X2

Contacts

Mary-Helen Blackall

905 -527-4322blackall @hhsc.ca

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Sep 20, 2007

Last verified

Sep, 2004

Keywords

  • patients undergoing cardiac surgery requiring cardiopulmonary bypass

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2007-09-20.