HEROIC (Heparin Requirement in Counterpulsation) (HEROIC)
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|ClinicalTrials.gov Identifier: NCT00445211|
Recruitment Status : Terminated (lack of enrollment)
First Posted : March 8, 2007
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiogenic Shock||Drug: Heparin Other: Without Heparin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Heparin Requirement in Counterpulsation|
|Study Start Date :||January 2006|
|Primary Completion Date :||March 2008|
|Study Completion Date :||March 2008|
Active Comparator: Intra-Aortic balloon Pump with Heparin
Intra-Aortic Balloon Pump (IABP) with Heparin
Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).
Active Comparator: Intra-Aortic balloon Pump without Heparin
Intra-Aortic balloon Pump (IABP) without Heparin
Other: Without Heparin
Intra-Aortic balloon Pump (IABP) without Heparin.
- Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization [ Time Frame: 0-4 days post surgery ]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
- Major Ischemia (Decreased Blood Flow) During the Index Hospitalization [ Time Frame: 0-4 days post surgery ]Count of participants with loss of Doppler signal or sensation or abnormal skin temperature, mottling or pallor in lower extremity requiring surgical intervention; or other major ischemic events including ischemic stroke; recurrent unstable ischemia (unstable angina, recurrent chest pain prompting definitive treatment such as re-percutaneous transluminal coronary angiography (PTCA), coronary artery bypass grafting (CABG), administration of thrombolytics); reinfarction including clinical symptoms or new ECG changes with creatine kinase (CK) elevation and positive creatine kinase-MB isoenzyme fraction; arterial thrombosis, embolus, dissection, or perforation; compartment syndrome; renal ischemia including new renal failure or need for dialysis; small bowel or splenic infarction; mesenteric or hepatic ischemia, or deep vein thrombosis.
- Major Bleeding During the Index Hospitalization [ Time Frame: 0-4 days post surgery ]Count of participants with hemorrhage associated with at least one of the following features as defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria: Bleeding that results in a decrease in hemoglobin >/= 5g.dL or a hematocrit decrease of >/= 15% of baseline value; bleeding that is intracranial (confirmed by MRI or CT); bleeding that results in death.
- Intra-aortic Balloon Pump-related Death During the Index Hospitalization [ Time Frame: 0-4 days post surgery ]
- Hospital Death During the Index Hospitalization [ Time Frame: 0-4 post surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445211
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Justin Trivax, M.D.||William Beaumont Hospitals|