Cardiac Valve Annuloplasty, Transcatheter Aortic Valve Replacement
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTiStat Handheld Blood Analyzer
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.
DIAGNOSTIC_TESTHemochron
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.
Sponsors
Rhode Island Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activated Clotting Time (ACT) | Baseline, 30 seconds and 180 seconds after IV heparin administration | Change in point of care activated clotting time (ACT) levels over time after IV heparin administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory-based anticoagulation | Baseline, 30 seconds and 180 seconds after IV heparin administration | Laboratory-based anticoagulation measure of anti-Xa and TEG levels will be compared to point of care activated clotting time (ACT) levels. |
Countries
United States
Contacts
Primary ContactShyamal Asher, M.D.
Outcome results
None listed