Hetastarch and Bleeding Complications After Off-Pump Coronary Bypass Surgery

This study has been completed.
Sponsor:
Collaborator:
Kaiser Foundation Research Institute
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00307138
First received: March 24, 2006
Last updated: May 19, 2006
Last verified: August 2005
  Purpose

There has been continuing debate about whether use of hetastarch for volume replacement in coronary artery bypass surgery [CABG] increases the risk of postoperative bleeding. A recent meta-analysis of hetastarch use in on-pump CABG concluded that use of hetastarch in these procedures is associated with increased risk, but the safety of hetastarch use in off-pump procedures remains unresolved.

We designed a double-blinded randomized clinical trial to investigate this question. The study was designed as an equivalence trial. Statistical power calculations were performed taking this into consideration. Sealed assignments from a block randomization table developed prior nto initiation of the trial were unsealed in the operating room. These were used to assign patients scheduled for off-pump CABG to receive either 1 L of hetastarch or 1 L of albumin as part of intraoperative volume replacement. Albumin was used for all subsequent intraoperative and postoperative fluid replacement.

The rate of postoperative bleeding was assessed prospectively by monitoring hourly chest tube drainage and number of units of blood products transfused postoperatively in the Intensive Care Unit. Risk was assessed by a Data Safety Monitoring Committee (DSMC) established for this trial. The SAMC was scheduled per protocol to meet after the first 15 subjects (both groups combined) had 1000cc or more of chest tube drainage in the first 12 hours postoperative, and then subsequently either after 15 additional bleeds of this volume or following a schedule set at the discretion of the DSMC.

The trial was continued until 156 patients had been recruited. At that time, 78 participants each had been assigned to the hetastarch and albumin groups. DSMC review at that time determined that use of hetastarch is associated with a risk of postoperative bleeding which is greater than the risk associated with use of albumin and the DSMC accordingly halted the trial.


Condition Intervention Phase
Postoperative Hemorrhage
Drug: hetastarch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Hetastarch (Hextend) and Bleeding Complications After Off-Pump Coronary Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • the number of units of packed red blood cells transfused within the first 24 hours after surgery
  • the number of units of fresh-frozen plasma transfused within the first 24 hours after surgery
  • the number of units of platelets transfused within the first 24 hours after surgery

Secondary Outcome Measures:
  • volume of chest tube drainage within the first 12 postoperative hours
  • reoperation for bleeding complications
  • duration of mechanical ventilation
  • length of stay in the intensive care unit
  • length of total postoperative hospital stay
  • ; and total mortality rates

Estimated Enrollment: 330
Study Start Date: September 2004
Estimated Study Completion Date: August 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled coronary bypass graft surgery that is planned to be conducted on adults off-pump (i.e., without use of cardio-pulmonary bypass).

Exclusion Criteria:

  • Scheduled coronary bypass graft surgery that is planned to be conducted on adults on-pump (i.e., with use of cardio-pulmonary bypass).
  • A history of cardiac surgery
  • A history of primary bleeding disorders
  • End-stage renal disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00307138

Locations
United States, California
Summit Medical Center
Oakland, California, United States, 94611
Sponsors and Collaborators
Kaiser Permanente
Kaiser Foundation Research Institute
Investigators
Principal Investigator: Marketa Hecht, MD Kaiser Permanente
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00307138     History of Changes
Other Study ID Numbers: Hetastarch_Off-pump_CABG
Study First Received: March 24, 2006
Last Updated: May 19, 2006
Health Authority: United States: Federal Government

Keywords provided by Kaiser Permanente:
Coronary artery bypass, Off-pump
Hetastarch
Plasma substitutes
Equivalence

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on October 16, 2014