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

Sponsor:

Information provided by (Responsible Party):

Justin Trivax, William Beaumont Hospitals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiogenic Shock	Drug: Heparin Other: Without Heparin	Phase 2

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, 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	46 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Heparin Requirement in Counterpulsation
Study Start Date :	January 2006
Actual Primary Completion Date :	March 2008
Actual Study Completion Date :	March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin Heparin sodium

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Intra-Aortic balloon Pump with Heparin Intra-Aortic Balloon Pump (IABP) with Heparin	Drug: 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.

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age >/= 18 years
Able to provide consent
Insertion of Intra-aortic Balloon Pump (IABP) in William Beaumont Hospital (WBH) cath lab
Anticipated duration of IABP >/= 18 hours

Exclusion Criteria:

Contraindications to heparin
Pre-existing condition requiring heparin administration (other than IABP)
IABP placed outside of the WBH cardiac catheterization lab prophylactically for high-risk percutaneous coronary intervention (PCI), without complications)
Pregnant women

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

William Beaumont Hospitals

Investigators

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Principal Investigator:	Justin Trivax, M.D.	William Beaumont Hospitals

More Information

Publications:

Baim DS, Grossman W. Grossman's Cardiac Catheterization, Angiography and Intervention (6th Ed). Lippincott Williams & Williams, Philadelphia, Pennsylvania, 2000, 463.

MOULOPOULOS SD, TOPAZ S, KOLFF WJ. Diastolic balloon pumping (with carbon dioxide) in the aorta--a mechanical assistance to the failing circulation. Am Heart J. 1962 May;63:669-75.

Kantrowitz A. Origins of intraaortic balloon pumping. Ann Thorac Surg. 1990 Oct;50(4):672-4.

Stone GW, Ohman EM, Miller MF, Joseph DL, Christenson JT, Cohen M, Urban PM, Reddy RC, Freedman RJ, Staman KL, Ferguson JJ 3rd. Contemporary utilization and outcomes of intra-aortic balloon counterpulsation in acute myocardial infarction: the benchmark registry. J Am Coll Cardiol. 2003 Jun 4;41(11):1940-5.

Cohen M, Dawson MS, Kopistansky C, McBride R. Sex and other predictors of intra-aortic balloon counterpulsation-related complications: prospective study of 1119 consecutive patients. Am Heart J. 2000 Feb;139(2 Pt 1):282-7.

Alle KM, White GH, Harris JP, May J, Baird D. Iatrogenic vascular trauma associated with intra-aortic balloon pumping: identification of risk factors. Am Surg. 1993 Dec;59(12):813-7.

Walls JT, Boley TM, Curtis JJ, Silver D. Heparin induced thrombocytopenia in patients undergoing intra-aortic balloon pumping after open heart surgery. ASAIO J. 1992 Jul-Sep;38(3):M574-6.

Ficek SJ, Stammers A, Deligonul U, Shurmur SW, Alonso A, Galbraith T. Hemostatic assessment of patients undergoing intraaortic balloon pump therapy. J Extra Corpor Technol. 1997 Jun;29(2):78-82.

Busch T, Sîrbu H, Zenker D, Dalichau H. Vascular complications related to intraaortic balloon counterpulsation: an analysis of ten years experience. Thorac Cardiovasc Surg. 1997 Apr;45(2):55-9.

Todd GJ, Bregman D, Voorhees AB, Reemtsma K. Vascular complications associated with percutaneous intra-aortic balloon pumping. Arch Surg. 1983 Aug;118(8):963-4.

Jiang CY, Zhao LL, Wang JA, Mohammod B. Anticoagulation therapy in intra-aortic balloon counterpulsation: does IABP really need anti-coagulation? J Zhejiang Univ Sci. 2003 Sep-Oct;4(5):607-11.

Sato K, Tokairin H, Kato M. [Two patients treated with intra-aortic balloon pump counterpulsation after subarachnoid hemorrhage]. Masui. 2001 Aug;50(8):859-62. Japanese.

Vonderheide RH, Thadhani R, Kuter DJ. Association of thrombocytopenia with the use of intra-aortic balloon pumps. Am J Med. 1998 Jul;105(1):27-32.

Schreiber TL, Kodali UR, O'Neill WW, Gangadharan V, Puchrowicz-Ochocki SB, Grines CL. Comparison of acute results of prophylactic intraaortic balloon pumping with cardiopulmonary support for percutaneous transluminal coronary angioplasty (PCTA). Cathet Cardiovasc Diagn. 1998 Oct;45(2):115-9.

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Responsible Party:	Justin Trivax, MD Cardiologist, William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00445211
Other Study ID Numbers:	2006-001
First Posted:	March 8, 2007 Key Record Dates
Results First Posted:	May 19, 2017
Last Update Posted:	May 19, 2017
Last Verified:	April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Justin Trivax, William Beaumont Hospitals:


Intraaortic balloon pumping Heparin Limb ischemia Bleeding

Additional relevant MeSH terms:

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Shock, Cardiogenic Myocardial Infarction Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Infarction Ischemia Pathologic Processes	Necrosis Shock Heparin Calcium heparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action

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