Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445211
Status:
TERMINATED
Last Update Posted:
2017-05-19
First Post:
2007-03-06
Brief Title:
HEROIC Heparin Requirement in Counterpulsation
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
Official Title:
Heparin Requirement in Counterpulsation
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEROIC
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 hisher 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 clotsdecreased 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 andor minimize complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None