Trial Outcomes & Findings for HEROIC (Heparin Requirement in Counterpulsation) (NCT NCT00445211)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

0-4 days post surgery

Results posted on

2017-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Intra-Aortic Balloon Pump With Heparin Intra-Aortic Balloon Pump (IABP) with Heparin Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).	Intra-Aortic Balloon Pump Without Heparin Intra-Aortic balloon Pump (IABP) without Heparin Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin.
Overall Study STARTED	23	23
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intra-Aortic Balloon Pump With Heparin n=23 Participants Intra-Aortic Balloon Pump (IABP) with Heparin Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).	Intra-Aortic Balloon Pump Without Heparin n=23 Participants Intra-Aortic balloon Pump (IABP) without Heparin Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin.	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=8 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients.	0 Participants n=9 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients.	0 Participants n=17 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients.
Age, Categorical Between 18 and 65 years	1 Participants n=8 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients.	3 Participants n=9 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients.	4 Participants n=17 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients.
Age, Categorical >=65 years	7 Participants n=8 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients.	6 Participants n=9 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients.	13 Participants n=17 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients.
Sex: Female, Male Female	1 Participants n=8 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients	4 Participants n=9 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients	5 Participants n=17 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients
Sex: Female, Male Male	7 Participants n=8 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients	5 Participants n=9 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients	12 Participants n=17 Participants • Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients

PRIMARY outcome

Timeframe: 0-4 days post surgery

Population: Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients

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

Outcome measures

Outcome measures
Measure	Intra-Aortic Balloon Pump With Heparin n=8 Participants Intra-Aortic Balloon Pump (IABP) with Heparin Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).	Intra-Aortic Balloon Pump Without Heparin n=9 Participants Intra-Aortic balloon Pump (IABP) without Heparin Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin.
Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 0-4 days post surgery

Population: Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients

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.

Outcome measures

Outcome measures
Measure	Intra-Aortic Balloon Pump With Heparin n=8 Participants Intra-Aortic Balloon Pump (IABP) with Heparin Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).	Intra-Aortic Balloon Pump Without Heparin n=9 Participants Intra-Aortic balloon Pump (IABP) without Heparin Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin.
Major Ischemia (Decreased Blood Flow) During the Index Hospitalization	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 0-4 days post surgery

Population: Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients

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.

Outcome measures

Outcome measures
Measure	Intra-Aortic Balloon Pump With Heparin n=8 Participants Intra-Aortic Balloon Pump (IABP) with Heparin Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).	Intra-Aortic Balloon Pump Without Heparin n=9 Participants Intra-Aortic balloon Pump (IABP) without Heparin Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin.
Major Bleeding During the Index Hospitalization	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0-4 days post surgery

Outcome measures

Outcome measures
Measure	Intra-Aortic Balloon Pump With Heparin n=23 Participants Intra-Aortic Balloon Pump (IABP) with Heparin Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).	Intra-Aortic Balloon Pump Without Heparin n=23 Participants Intra-Aortic balloon Pump (IABP) without Heparin Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin.
Intra-aortic Balloon Pump-related Death During the Index Hospitalization	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0-4 post surgery

Outcome measures

Outcome measures
Measure	Intra-Aortic Balloon Pump With Heparin n=23 Participants Intra-Aortic Balloon Pump (IABP) with Heparin Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).	Intra-Aortic Balloon Pump Without Heparin n=23 Participants Intra-Aortic balloon Pump (IABP) without Heparin Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin.
Hospital Death During the Index Hospitalization	0 Participants	0 Participants

Adverse Events

Intra-Aortic Balloon Pump With Heparin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intra-Aortic Balloon Pump Without Heparin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Justin Trivax

William Beaumont Hospital

Phone: (248)587-2300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place