CClinicalTrials.gg
Status unknownNCT00182377Updated Sep 20, 2007

Pentastarch Use in Cardiac Surgery

An interventional study of Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch) in Cardiac Surgery and Cardiopulmonary Bypass, sponsored by Hamilton Health Sciences Corporation. Status unknown at 1 site in Canada. Per ClinicalTrials.gov, last updated 2007-09-20.

Sponsored by Hamilton Health Sciences Corporation · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2004), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Allocation
Randomized
Sex
All
01

Study 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?

02

Conditions studied

  • Cardiac Surgery
  • Cardiopulmonary Bypass

Keywords

  • patients undergoing cardiac surgery requiring cardiopulmonary bypass
03

In context

Lead sponsor

Hamilton Health Sciences Corporation is the lead sponsor of 237 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double

Interventions

  • DrugPentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)
06

What researchers measure

Primary outcomes

  1. transfusion requirements

  2. fluid balance

Secondary outcomes

  1. postoperative bleeding

  2. mediastinal drainage

  3. coagulation parameters

  4. respiratory status

07

Study locations

1 of 1 sites recruiting
  • Hamilton Health Sciences - General Division
    Hamilton, Ontario lL8L 2X2, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00182377
Lead sponsor
Hamilton Health Sciences Corporation
First posted
Sep 16, 2005
Last update
Sep 20, 2007

Study contacts

Irene Cybulsky, MD
Contact
cybulsky@hhsc.ca
905-777-8248
Irene Cybulsky, MD
principal investigator · McMaster University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2004. You cannot join it, but the record below documents what was studied.

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