Assessment of Clinical Onset of IV Heparin in Interventional Cardiology and Cardiac Surgery

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Assessment of Clinical Onset of IV Heparin in Interventional Cardiology and Cardiac Surgery

Conditions
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Transcatheter Aortic Valve Replacement, Cardiac Valve Annuloplasty

Intervention / Treatment
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* Diagnostic Test: iStat Handheld Blood Analyzer
* Diagnostic Test: Hemochron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult cardiac surgery patients presenting for elective valvular surgery Interventional cardiology patients presenting elective Transcatheter Aortic Valve Replacement (TAVR) Exclusion Criteria: Preoperative IV heparin administration within 12 hours of surgery Preoperative oral anticoagulant use within 24 hours of surgery Platelet count <120,000U/ml within 24 hours of surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transcatheter Aortic Valve Replacement<br>Patients receive 100U/Kg of IV heparin. An arterial sample activated clotting time (ACT) will be checked by iStat and hemochron | Diagnostic Test: iStat Handheld Blood Analyzer<br>* 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.<br>Diagnostic Test: Hemochron<br>* 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.<br>|
| Cardiac Valve Annuloplasty<br>Patients receive 300U/kg of IV heparin. An arterial sample activated clotting time (ACT) will be checked by iStat and hemochron | Diagnostic Test: iStat Handheld Blood Analyzer<br>* 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.<br>Diagnostic Test: Hemochron<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |