A Phase 2 interventional study of Heparin and Without Heparin in Cardiogenic Shock, sponsored by William Beaumont Hospitals. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-19.
Sponsored by William Beaumont Hospitals · Phase 2, Interventional, and Treatment
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.
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.
277 studies on the registry are indexed under Shock, Cardiogenic; 127 are open to participants now.
This study's enrollment of 46 is below the median of 80 across 127 interventional studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intra-Aortic Balloon Pump (IABP) with Heparin
Drug: Heparin
Intra-Aortic balloon Pump (IABP) without Heparin
Other: Without Heparin
Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).
Intra-Aortic balloon Pump (IABP) without Heparin.
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
Time frame: 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.
Time frame: 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.
Time frame: 0-4 days post surgery
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
| Milestone | Intra-Aortic Balloon Pump With Heparin | Intra-Aortic Balloon Pump Without Heparin |
|---|---|---|
| Started | 23 | 23 |
| Completed | 23 | 23 |
| Not completed | 0 | 0 |
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
| Participants | Intra-Aortic Balloon Pump With Heparin | Intra-Aortic Balloon Pump Without Heparin |
|---|---|---|
| Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization | 0 | 0 |
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.
| Participants | Intra-Aortic Balloon Pump With Heparin | Intra-Aortic Balloon Pump Without Heparin |
|---|---|---|
| Major Ischemia (Decreased Blood Flow) During the Index Hospitalization | 0 | 0 |
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.
| Participants | Intra-Aortic Balloon Pump With Heparin | Intra-Aortic Balloon Pump Without Heparin |
|---|---|---|
| Major Bleeding During the Index Hospitalization | 0 | 0 |
| Participants | Intra-Aortic Balloon Pump With Heparin | Intra-Aortic Balloon Pump Without Heparin |
|---|---|---|
| Intra-aortic Balloon Pump-related Death During the Index Hospitalization | 0 | 0 |
| Participants | Intra-Aortic Balloon Pump With Heparin | Intra-Aortic Balloon Pump Without Heparin |
|---|---|---|
| Hospital Death During the Index Hospitalization | 0 | 0 |
Collected over Time IntraAortic Balloon Pump (IABP) was inserted in the catheterization laboratory to length of stay in hospital.. 0-4 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intra-Aortic Balloon Pump With Heparin | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Intra-Aortic Balloon Pump Without Heparin | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Age, Categorical(Participants) | Intra-Aortic Balloon Pump With Heparin | Intra-Aortic Balloon Pump Without Heparin | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 3 | 4 |
| >=65 years | 7 | 6 | 13 |
| Sex: Female, Male(Participants) | Intra-Aortic Balloon Pump With Heparin | Intra-Aortic Balloon Pump Without Heparin | Total |
|---|---|---|---|
| Female | 1 | 4 | 5 |
| Male | 7 | 5 | 12 |
Plan to share: No
This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
William Beaumont Hospitals