- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00445211
HEROIC (Heparin Requirement in Counterpulsation) (HEROIC)
April 11, 2017 updated by: Justin Trivax, William Beaumont Hospitals
Heparin Requirement in Counterpulsation
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Intra-Aortic balloon Pump (IABP) without Heparin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0-4 days post surgery
|
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.
|
0-4 days post surgery
|
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.
|
0-4 days post surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intra-aortic Balloon Pump-related Death During the Index Hospitalization
Time Frame: 0-4 days post surgery
|
0-4 days post surgery
|
Hospital Death During the Index Hospitalization
Time Frame: 0-4 post surgery
|
0-4 post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Justin Trivax, M.D., William Beaumont Hospitals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1016/0002-8703(62)90012-1. No abstract available.
- Kantrowitz A. Origins of intraaortic balloon pumping. Ann Thorac Surg. 1990 Oct;50(4):672-4. doi: 10.1016/0003-4975(90)90220-z.
- 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. doi: 10.1016/s0735-1097(03)00400-5.
- 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. doi: 10.1067/mhj.2000.101489.
- 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. doi: 10.1097/00002480-199207000-00100.
- 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, Sirbu 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. doi: 10.1055/s-2007-1013687.
- 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. doi: 10.1001/archsurg.1983.01390080065016.
- 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. doi: 10.1631/jzus.2003.0607.
- 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. doi: 10.1016/s0002-9343(98)00128-4.
- 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. doi: 10.1002/(sici)1097-0304(199810)45:23.0.co;2-f.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
March 6, 2007
First Submitted That Met QC Criteria
March 7, 2007
First Posted (Estimate)
March 8, 2007
Study Record Updates
Last Update Posted (Actual)
May 19, 2017
Last Update Submitted That Met QC Criteria
April 11, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Shock
- Myocardial Infarction
- Infarction
- Shock, Cardiogenic
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin
- Calcium heparin
Other Study ID Numbers
- 2006-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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