Clinical trial NCT00445211: HEROIC (Heparin Requirement in Counterpulsation)
Official title: Heparin Requirement in Counterpulsation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cardiogenic Shock
Keywords: Intraaortic balloon pumping
Heparin
Limb ischemia
Bleeding
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2007-03-08
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Potential patients will be identified in the cardiac catheterization lab when an intra-aortic balloon pump is placed. Patients who agree to participate in this study will be randomized (they will be selected to receive heparin or not to receive heparin with their intra-aortic balloon pump) by a process that is similar to flipping a coin. Patients will have a 50% chance of receiving heparin and a 50% chance of not receiving heparin. If a patient does not want to participate in the study, his/her cardiologist will decide if the patient will receive or not receive heparin. Intra-aortic balloon pumps have been used with and without intravenous heparin and there is no known increase in complications in patients who do not receive heparin. Risks include bleeding and possible blood clots/decreased blood flow to the leg with the catheter in both groups (due to different medical reasons). The patients in both groups will be monitored closely in the cardiac care unit while the intra-aortic balloon pump is in place to prevent and/or minimize complications.

Eligibility criteria: Inclusion Criteria:

* Age \>/= 18 years
* Able to provide consent
* Insertion of Intra-aortic Balloon Pump (IABP) in William Beaumont Hospital (WBH) cath lab
* Anticipated duration of IABP \>/= 18 hours

Exclusion Criteria:

* Contraindications to heparin
* Pre-existing condition requiring heparin administration (other than IABP)
* IABP placed outside of the WBH cardiac catheterization lab prophylactically for high-risk percutaneous coronary intervention (PCI), without complications)
* Pregnant women

Primary outcomes:
measure: Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization
timeFrame: 0-4 days post surgery
measure: Major Ischemia (Decreased Blood Flow) During the Index Hospitalization
timeFrame: 0-4 days post surgery
measure: Major Bleeding During the Index Hospitalization
timeFrame: 0-4 days post surgery
Secondary outcomes:
measure: Intra-aortic Balloon Pump-related Death During the Index Hospitalization
timeFrame: 0-4 days post surgery
measure: Hospital Death During the Index Hospitalization
timeFrame: 0-4 post surgery
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Justin Trivax, M.D.
role: PRINCIPAL_INVESTIGATOR
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