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NCT00445211 · ClinicalTrials.gov registry record · Phase 2
HEROIC (Heparin Requirement in Counterpulsation)
A Phase 2 study, sponsored by Corewell Health East.
- Terminated
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT00445211: Clinical Trial Phase 2 study, sponsored by Corewell Health East.
NCT00445211 is a Phase 2 study that was terminated before completion, run by Corewell Health East. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00445211, a Phase 2 study, was terminated before completion, sponsored by Corewell Health East.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
Patients with intra-aortic balloon pumps (catheters placed in the groin connected to a pump which assists the heart by opening and closing a balloon in the aorta, thereby decreasing the work of the heart and improving blood flow to the coronary arteries) often receive intravenous (IV) heparin (a "blood thinner") to prevent circulation problems in the leg (where they are inserted). When intra-aortic balloon pumps were initially developed, the catheters were larger than the catheters used today. Due to the large size of the catheter and the material used to make the catheter, it was thought that intravenous heparin would prevent poor blood flow to the leg that contained the temporary catheter. Intravenous heparin, however, has never been proven to maintain good blood flow in these patients. The catheters used with intra-aortic balloon pumps are now smaller in size and made of a material that is less likely to produce blood clots. It is not clear that heparin is needed with intra-aortic balloon pumps. Bleeding complications associated with intra-aortic balloon pumps may be decreased if heparin is not used. In 2004, 99 patients received intra-aortic balloon pumps in the cardiac catheterization labs at William Beaumont Hospital. These patients received intravenous heparin and experienced a large number of bleeding complications (27 patients required a blood transfusion). This study will help the investigators to clarify if heparin should or should not be routinely used in patients with intra-aortic balloon pumps.
Primary Outcome
Count of participants with decreased arterial flow in lower extremity as presented by diminished pulse that resolves with balloon removal, and not resulting in any impairment of body function
Interventions
- DRUG Heparin
- OTHER Without Heparin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2006-01 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
Why NCT00445211 stopped before completion
NCT00445211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Heparin is the first listed.
NCT00445211 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00445211 about?
NCT00445211 is a clinical study titled "HEROIC (Heparin Requirement in Counterpulsation)". Patients with intra-aortic balloon pumps (catheters placed in the groin connected to a pump which assists the heart by opening and closing a balloon in the aorta, thereby decreasing the work of the heart and improving blood flow to the coronary arteries) often receive intravenous (IV) heparin (a "bl...
What is the current status of trial NCT00445211?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2006-01. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00445211?
The interventions under investigation include: Heparin (DRUG), Without Heparin (OTHER).
Who is sponsoring clinical trial NCT00445211?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00445211's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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