HEROIC (Heparin Requirement in Counterpulsation) (HEROIC)
|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|
|Actual Primary Completion Date :||March 2008|
|Actual 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 ]
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|