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The efficiency and promptness of heparin anticoagulation is necessary during the structural heart procedures to minimize time from insertion of cannulae to valve deployment in cardiac surgery. The goal of this study is to determine how rapidly the adequacy of heparin induced anticoagulation occurs using two different point of care activated clotting time technologies (iSTAT and Hemochron).
Adequate anticoagulation is achieved in cardiac surgery and interventional cardiology procedures with intravenous (IV) administration of unfractionated heparin. The Activated clotting time (ACT) is routinely measured to assess adequacy of anticoagulation to prevent clotting/thrombotic complications from placement of foreign materials used during cardiac surgery and cardiology procedures. Alternative methods to measure adequacy of anticoagulation such as measurement of Anti-Xa level and Reaction (R) time as assessed by Thromboelastrography (TEG) have also been suggested. However, their use in clinical practice is limited by lack of Point of Care (POC) technology and need for additional expertise to run these tests.
The efficiency and promptness of heparin anticoagulation is necessary during the structural heart procedures to minimize time from insertion of cannulae to valve deployment in cardiac surgery. The time required to prevent major complications is on the order of seconds to minutes. The goal of this study is to determine how rapidly the adequacy of heparin induced anticoagulation occurs using two different point of care ACT technologies (iSTAT and Hemochron). It is hypothesized that anticoagulation can be determined by the iSTAT ACT device 30 seconds after administration of heparin. Measuring heparin effectiveness at 30 or 90 seconds instead of the usual 3-minute time period may allow for earlier cardiac intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter Aortic Valve Replacement | Patients receive 100U/Kg of IV heparin. An arterial sample activated clotting time (ACT) will be checked by iStat and hemochron |
| |
| Cardiac Valve Annuloplasty | Patients receive 300U/kg of IV heparin. An arterial sample activated clotting time (ACT) will be checked by iStat and hemochron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStat Handheld Blood Analyzer | Diagnostic Test | An easy-to-use blood analyzer that provides monitoring of heparin anticoagulation quickly for point-of-care testing. Testing will be done at baseline, 30s, 90s and 180s after heparin administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Activated Clotting Time (ACT) | Change in point of care activated clotting time (ACT) levels over time after IV heparin administration | Baseline, 30 seconds and 180 seconds after IV heparin administration |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory-based anticoagulation | Laboratory-based anticoagulation measure of anti-Xa and TEG levels will be compared to point of care activated clotting time (ACT) levels. | Baseline, 30 seconds and 180 seconds after IV heparin administration |
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Inclusion Criteria:
Exclusion Criteria:
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Adult cardiac surgical patients with intravenous (IV) administration of unfractionated heparin.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shyamal Asher, M.D. | Contact | (401) 444-5172 | sasher@lifespan.org |
| Name | Affiliation | Role |
|---|---|---|
| Shyamal Asher, M.D. | Rhode Island Hospital, Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32620484 | Background | Falter F, MacDonald S, Matthews C, Kemna E, Canameres J, Besser M. Evaluation of Point-of-Care ACT Coagulometers and Anti-Xa Activity During Cardiopulmonary Bypass. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2921-2927. doi: 10.1053/j.jvca.2020.06.027. Epub 2020 Jun 12. | |
| 28359133 | Background | Bolliger D, Tanaka KA. Point-of-Care Coagulation Testing in Cardiac Surgery. Semin Thromb Hemost. 2017 Jun;43(4):386-396. doi: 10.1055/s-0037-1599153. Epub 2017 Mar 30. |
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| Hemochron | Diagnostic Test | An easy-to-use blood analyzer that provides monitoring of heparin anticoagulation quickly for point-of-care testing. Testing will be done at baseline, 30s, 90s and 180s after heparin administration. |
|
| 11375810 | Background | Heres EK, Speight K, Benckart D, Marquez J, Gravlee GP. The clinical onset of heparin is rapid. Anesth Analg. 2001 Jun;92(6):1391-5. doi: 10.1097/00000539-200106000-00006. |