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NCT00307138 · ClinicalTrials.gov registry record · Phase 3
Hetastarch and Bleeding Complications After Off-Pump Coronary Bypass Surgery
A Phase 3 study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- Phase 3
- Development phase
- 330
- Enrollment target
NCT00307138 is a Phase 3 study that has completed, run by Kaiser Permanente. The registered enrollment target is 330 participants.
The verdict
NCT00307138, a Phase 3 study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG hetastarch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2004-09 |
| Est. Completion | 2005-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00307138
The ClinicalTrials.gov registry entry for NCT00307138 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which hetastarch is the first listed.
NCT00307138 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00307138 about?
NCT00307138 is a clinical study titled "Hetastarch and Bleeding Complications After Off-Pump Coronary Bypass Surgery". 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...
What is the current status of trial NCT00307138?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2004-09. Estimated completion is 2005-08.
What interventions are being tested in trial NCT00307138?
The interventions under investigation include: hetastarch (DRUG).
Who is sponsoring clinical trial NCT00307138?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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