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HEROIC (Heparin Requirement in Counterpulsation) (HEROIC)

This study has been terminated.
(lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Justin Trivax, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00445211
First received: March 6, 2007
Last updated: April 11, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Cardiogenic Shock
Drug: Heparin
Other: Without Heparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Heparin Requirement in Counterpulsation

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

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 ]

Enrollment: 46
Study Start Date: January 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445211

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
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.
Stone GW, Ohman EM, Miller MF, Joseph DL, Christenson JT, Cohen M, Urban PM, Reddy RC. Contemporary utilization and outcomes of intra-aortic balloon counterpulsation. Am J Cardiol, 1993; 71:328-332.

Responsible Party: Justin Trivax, MD Cardiologist, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00445211     History of Changes
Other Study ID Numbers: 2006-001
Study First Received: March 6, 2007
Results First Received: April 11, 2017
Last Updated: April 11, 2017
Individual Participant Data  
Plan to Share IPD: No

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

Keywords provided by William Beaumont Hospitals:
Intraaortic balloon pumping
Heparin
Limb ischemia
Bleeding

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

ClinicalTrials.gov processed this record on May 22, 2017