HEROIC (Heparin Requirement in Counterpulsation)

NCT00445211 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2006-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock

Keywords

Intraaortic balloon pumping; Heparin; Limb ischemia; Bleeding

Outcome Measures

Primary Outcomes (3)

• Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization

  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

  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

  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 Outcomes (2)

• Intra-aortic Balloon Pump-related Death During the Index Hospitalization

  0-4 days post surgery

• Hospital Death During the Index Hospitalization

  0-4 post surgery

Study Arms (2)

Intra-Aortic balloon Pump with Heparin

ACTIVE COMPARATOR

Intra-Aortic Balloon Pump (IABP) with Heparin

Drug: Heparin

Intra-Aortic balloon Pump without Heparin

ACTIVE COMPARATOR

Intra-Aortic balloon Pump (IABP) without Heparin

Other: Without Heparin

Interventions

Heparin DRUG

Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).

Intra-Aortic balloon Pump with Heparin

Without Heparin OTHER

Intra-Aortic balloon Pump (IABP) without Heparin.

Intra-Aortic balloon Pump without Heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (14)

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

  BACKGROUND

• 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.

  PMID: 14476645 BACKGROUND

• Kantrowitz A. Origins of intraaortic balloon pumping. Ann Thorac Surg. 1990 Oct;50(4):672-4. doi: 10.1016/0003-4975(90)90220-z.

  PMID: 2222066 BACKGROUND

• 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.

  PMID: 12798561 BACKGROUND

• 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.

  PMID: 10650301 BACKGROUND

• 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.

  PMID: 8256934 BACKGROUND

• 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.

  PMID: 1457924 BACKGROUND

• 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.

  PMID: 10168534 BACKGROUND

• 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.

  PMID: 9175219 BACKGROUND

• 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.

  PMID: 6870526 BACKGROUND

• 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.

  PMID: 12958723 BACKGROUND

• 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.

  PMID: 11554017 BACKGROUND

• 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.

  PMID: 9688018 BACKGROUND

• 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.

  PMID: 9786386 BACKGROUND

MeSH Terms

Conditions

Shock, Cardiogenic; Hemorrhage

Interventions

Heparin

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

Early termination leading to small number of subjects analyzed.

Results Point of Contact

• Title: Dr. Justin Trivax
• Organization: William Beaumont Hospital

Justin.Trivax@beaumont.edu

(248)587-2300

Study Officials

• Justin Trivax, M.D.

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Cardiologist

Study Record Dates

• First Submitted: March 6, 2007
• First Posted: March 8, 2007
• Study Start: January 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: May 19, 2017
• Results First Posted: May 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)