Clinical trial NCT04785885: Assessment of Clinical Onset of IV Heparin in Interventional Cardiology and Cardiac Surgery
Official title: Assessment of Clinical Onset of IV Heparin in Interventional Cardiology and Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transcatheter Aortic Valve Replacement
Cardiac Valve Annuloplasty
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult cardiac surgical patients with intravenous (IV) administration of unfractionated heparin.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Activated Clotting Time (ACT)
timeFrame: Baseline, 30 seconds and 180 seconds after IV heparin administration
Secondary outcomes:
measure: Laboratory-based anticoagulation
timeFrame: Baseline, 30 seconds and 180 seconds after IV heparin administration
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital, Brown University
name: Shyamal Asher, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.