HEROIC (Heparin Requirement in Counterpulsation)

Cardiogenic Shock Clinical Trial

— HEROIC  

Official title:

Heparin Requirement in Counterpulsation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445211
• Other study ID #: 2006-001
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2007
• Last updated: September 19, 2016
• Start date: January 2006
• Est. completion date: March 2008

Study information

• Verified date: September 2016
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >/= 18 years

• Able to provide consent

• Insertion of Intra-aortic Balloon Pump (IABP) in 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 PCI, without complications)

• Pregnant women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock, Cardiogenic

Intervention

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

Other:
• Without Heparin
Intra-Aortic balloon Pump (IABP) without Heparin.

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Justin Trivax

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minor ischemia (decreased blood flow)during the index hospitalization		4 days post surgery	Yes
Primary	Major ischemia (decreased blood flow) during the index hospitalization		2 days post surgery	Yes
Primary	Major bleeding during the index hospitalization		4 days post surgery	Yes
Secondary	Intra-aortic balloon pump-related death during the index hospitalization		post surgery	Yes
Secondary	Hospital death during the index hospitalization		post surgery	Yes