Cardiogenic Shock
Conditions
Keywords
Intraaortic balloon pumping, Heparin, Limb ischemia, Bleeding
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.
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.
Interventions
DRUGHeparin
Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).
OTHERWithout Heparin
Intra-Aortic balloon Pump (IABP) without Heparin.
Sponsors
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization | 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 | 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 | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intra-Aortic Balloon Pump With Heparin Intra-Aortic Balloon Pump (IABP) with Heparin
Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP). | 23 |
| Intra-Aortic Balloon Pump Without Heparin Intra-Aortic balloon Pump (IABP) without Heparin
Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin. | 23 |
| Total | 46 |
Baseline characteristics
| Characteristic | Intra-Aortic Balloon Pump With Heparin | Intra-Aortic Balloon Pump Without Heparin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
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
Population: Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intra-Aortic Balloon Pump With Heparin | Major Bleeding During the Index Hospitalization | 0 Participants |
| Intra-Aortic Balloon Pump Without Heparin | Major Bleeding During the Index Hospitalization | 0 Participants |
Primary
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
Population: Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intra-Aortic Balloon Pump With Heparin | Major Ischemia (Decreased Blood Flow) During the Index Hospitalization | 0 Participants |
| Intra-Aortic Balloon Pump Without Heparin | Major Ischemia (Decreased Blood Flow) During the Index Hospitalization | 0 Participants |
Primary
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
Population: Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intra-Aortic Balloon Pump With Heparin | Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization | 0 Participants |
| Intra-Aortic Balloon Pump Without Heparin | Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization | 0 Participants |
Secondary
Hospital Death During the Index Hospitalization
Time frame: 0-4 post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intra-Aortic Balloon Pump With Heparin | Hospital Death During the Index Hospitalization | 0 Participants |
| Intra-Aortic Balloon Pump Without Heparin | Hospital Death During the Index Hospitalization | 0 Participants |
Secondary
Intra-aortic Balloon Pump-related Death During the Index Hospitalization
Time frame: 0-4 days post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intra-Aortic Balloon Pump With Heparin | Intra-aortic Balloon Pump-related Death During the Index Hospitalization | 0 Participants |
| Intra-Aortic Balloon Pump Without Heparin | Intra-aortic Balloon Pump-related Death During the Index Hospitalization | 0 Participants |