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This study evaluates two different methods for monitoring a patient's anti-clotting [heparin] therapy after they receive a heart pump implant [left ventricular assist device -LVAD]. One method tests for how long it takes the patient's blood to clot and uses that to determine if they are on the right dose of heparin. The other method uses a more direct measure of how much heparin is in the blood. The hypothesis is that the method that more directly measures how much heparin is in the patient's blood will provide better medical results for the patient's care after they have the heart pump implant. To that end, the investigators are conducting this feasibility trial to establish the logistics associated with the implementation of these heparin monitoring approaches.
Heart failure is a medical condition that is on the rise in the US and is associated with an enormous cost of $30 billion in healthcare expenses. People with heart failure may be treated with an LVAD that is connected to their heart and helps it pump the blood from the left side of the heart into the blood vessels that delivers blood to the body. These devices can be used to treat heart failure for the long term or they can be used while a patient waits for a heart transplant. In either case, the use of these devices is increasing.
One of the primary risks associated with LVADs are those related to blood clotting. Maintenance of the LVAD depends on preventing blood clots especially right after the surgery that puts them in place. This requires putting patients with LVADs on blood thinners and then monitoring the blood thinner levels carefully so that they don't have problems with bleeding too easily or, on the other hand, forming blood clots if they aren't on the right dose of blood thinners. Excessive bleeding - called hemorrhaging - is the more common problem after surgery and half of all patients that receive an LVAD will require a blood transfusion within the first 30 days after they receive the device. A laboratory test that measures how quickly blood clots is used to determine if the patient has the right amount of blood thinners. The current standard test is called "activated partial thromboplastin time [aPTT]." There are problems with the reliability of this test because it reacts with other elements in the blood. Alternately, there is a test that more directly measures the amount of heparin blood thinner rather than coagulation time and may be more reliable than aPTT called anti-factor Xa [anti-Xa].
The investigators have developed process diagrams that show steps for making decisions [called nomograms] that tell a nurse or doctor how to manage the heparin levels using test results from the aPTT test or the anti-Xa test; however, both tests will be performed at each decision time point, but the care team will only be told the results from the testing to which their patient is assigned.
The purpose of this feasibility study is to establish feasibility of using the two nomograms to determine which provides the optimal clinical information for improving patients' outcomes that have had LVADs placed.
Potential subjects will be recruited prior to their surgery and may decline to participate anytime before or after the surgery takes place. Subjects will be randomized to the aPTT nomogram or the anti-Xa nomogram. If they withdraw consent, they will receive the aPTT standard of care monitoring. The study procedures are performed by the clinical care team. Clinicians will be trained to use the nomograms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aPTT nomogram | Active Comparator | aPTT guided heparin management |
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| Anti-factor Xa nomogram | Experimental | Anti-factor Xa guided heparin management |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aPTT guided heparin management | Device | post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device. |
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| Measure | Description | Time Frame |
|---|---|---|
| Nomogram Feasibility | Questionnaires evaluating pragmatic application of nomograms. Question 1: The current heparin nomogram using (aPTT or anti-Xa depending on group) monitoring is easy to follow. | 14 days of heparin therapy |
| Nomogram Feasibility | Questionnaires evaluating pragmatic application of nomograms. Question 2: Overall, I am satisfied with the utilization and implementation of the heparin monitoring nomogram. | 14 days of heparin therapy |
| Nomogram Feasibility | Questionnaires evaluating pragmatic application of nomograms. Question 3: Overall, I feel that this dosing nomogram is feasible. | 14 days of heparin therapy |
| Nomogram Feasibility | Questionnaires evaluating pragmatic application of nomograms. Question 4: When my patient is on the heparin nomogram, I follow the dosing and monitoring instructions exactly. | 14 days of heparin therapy |
| Nomogram Feasibility | Questionnaires evaluating pragmatic application of nomograms. Question 5: I often had to seek clarification from a coworker, pharmacist, NP, or MD regarding the nomogram instructions. | 14 days of heparin therapy |
| Success of Nomogram | Amount of time sustained in therapeutic anticoagulation range | 14 days of heparin therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Nomogram Concordance | Compare heparin dosing success between aPTT and anti-factor Xa nomograms. If aPTT was within therapeutic range of nomogram AND anti-factor Xa was within range in therapeutic nomogram, then paired values were deemed "concordent". Similiarly if both aPTT AND anti-factor Xa were above therapeutic range OR both below therapeutic range, then paired valued were deemed "concordent". Otherwise values deemd "discordant" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J Graetz, MD | Dept of Anesthesiology, Washington University STL SOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St Louis School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | aPTT Nomogram | aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device. Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2017 |
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| Anti-factor Xa guided heparin management | Device | post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device |
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| 14 days of heparin therapy |
| Dosing Changes | Number of dosing changes during heparin therapy until first therapeutic | 14 days of heparin therapy |
| Time to Therapeutic Dose | Amount of time needed to achieve therapeutic dose from heparin initiation | 14 days of heparin therapy |
| Anti-factor Xa Nomogram |
Anti-factor Xa guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device. Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device |
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| NOT COMPLETED |
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10 patients, that met all inclusion and exclusion criteria, were enrolled in each arm
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| ID | Title | Description |
|---|---|---|
| BG000 | aPTT Nomogram | aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device. Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device |
| BG001 | Anti-factor Xa Nomogram | Anti-factor Xa guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device. Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| INTERMACS Profile score less than 4 | INTERMACS(R) (Interagency Registry of Mechanically Assisted Circulatory Support) patient profile at the time of implant is a general description of patients receiving LVADs. INTERMACS(R) profile 1 is in Critical cardiogenic shock. INTERMACS(R) profile 2 is in Progressive decline. INTERMACS(R) profile 3 is Stable but inotrope dependent. INTERMACS(R) profile 4 is Resting symptoms. INTERMACS(R) profile 5 is Exertion intolerant. INTERMACS(R) profile 6 is Exertion limited. INTERMACS(R) profile 7 is Advanced NYHA Class 3. The lower the INTERMACS(R) profile, the more severe their heart failure. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Nomogram Feasibility | Questionnaires evaluating pragmatic application of nomograms. Question 1: The current heparin nomogram using (aPTT or anti-Xa depending on group) monitoring is easy to follow. | Posted | Number | Surveys | 14 days of heparin therapy | Surveys | Surveys |
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| Primary | Nomogram Feasibility | Questionnaires evaluating pragmatic application of nomograms. Question 2: Overall, I am satisfied with the utilization and implementation of the heparin monitoring nomogram. | Collected Survey responses from bedside nurses. All surveys were collected as intended. | Posted | Number | Surveys | 14 days of heparin therapy | Surveys | Surveys |
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| Primary | Nomogram Feasibility | Questionnaires evaluating pragmatic application of nomograms. Question 3: Overall, I feel that this dosing nomogram is feasible. | Collected Survey responses from bedside nurses. All surveys were collected as intended. | Posted | Number | Surveys | 14 days of heparin therapy | Surveys | Surveys |
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| Primary | Nomogram Feasibility | Questionnaires evaluating pragmatic application of nomograms. Question 4: When my patient is on the heparin nomogram, I follow the dosing and monitoring instructions exactly. | Posted | Number | Surveys | 14 days of heparin therapy | Surveys | Surveys |
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| Primary | Nomogram Feasibility | Questionnaires evaluating pragmatic application of nomograms. Question 5: I often had to seek clarification from a coworker, pharmacist, NP, or MD regarding the nomogram instructions. | Posted | Number | Surveys | 14 days of heparin therapy | Surveys | Surveys |
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| Primary | Success of Nomogram | Amount of time sustained in therapeutic anticoagulation range | Each group received heparin anticoagulation and had heparin administration guided by a nomogram based on one of two different laboratory assays, aPTT or anti-Xa. | Posted | Median | Inter-Quartile Range | % of time patients test was therapeutic | 14 days of heparin therapy |
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| Secondary | Nomogram Concordance | Compare heparin dosing success between aPTT and anti-factor Xa nomograms. If aPTT was within therapeutic range of nomogram AND anti-factor Xa was within range in therapeutic nomogram, then paired values were deemed "concordent". Similiarly if both aPTT AND anti-factor Xa were above therapeutic range OR both below therapeutic range, then paired valued were deemed "concordent". Otherwise values deemd "discordant" | paired aPTT samples compared with antiXa samples | Posted | Count of Units | tests | 14 days of heparin therapy | tests | tests |
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| Secondary | Dosing Changes | Number of dosing changes during heparin therapy until first therapeutic | Posted | Median | Inter-Quartile Range | dosing changes | 14 days of heparin therapy |
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| Secondary | Time to Therapeutic Dose | Amount of time needed to achieve therapeutic dose from heparin initiation | Posted | Median | Inter-Quartile Range | hours | 14 days of heparin therapy |
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Collected during 14 day study duration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | aPTT Nomogram | aPTT guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device. Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device | 0 | 10 | 2 | 10 | 0 | 10 |
| EG001 | Anti-factor Xa Nomogram | Anti-factor Xa guided heparin management aPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device. Anti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device | 0 | 10 | 3 | 10 | 0 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombosis | Blood and lymphatic system disorders | Systematic Assessment | Thrombotic events |
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| Bleeding Complication | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas J Graetz | WASHINGTON UNIVERSITY | 3147474155 | graetzt@wustl.edu |
| Jun 27, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006471 | Gastrointestinal Hemorrhage |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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