HEROIC (Heparin Requirement in Counterpulsation)



Status:Archived
Conditions:Cardiology, Hospital
Therapuetic Areas:Cardiology / Vascular Diseases, Other
Healthy:No
Age Range:Any
Updated:7/1/2011

Use our guide to learn which trials are right for you!

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 “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.


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.


We found this trial at
1
site
3601 West 13 Mile Road
Royal oak, Michigan 48073
?
mi
from
Royal oak, MI
Click here to add this to my saved trials