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

Transcatheter Aortic Valve Replacement Clinical Trial

— ACTPOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04785885
• Other study ID #: 1651774
• Status: Recruiting
• Start date: March 9, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: September 2021
• Source: Rhode Island Hospital
• Contact: Shyamal Asher, M.D.
• Phone: (401) 444-5172
• Email: sasher[@]lifespan.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2022
• Est. primary completion date: March 31, 2022
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Valve Annuloplasty
• Transcatheter Aortic Valve Replacement

Intervention

Diagnostic Test:
• iStat 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.
• Hemochron
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.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View Citation

Falter F, MacDonald S, Matthews C, Kemna E, Cañameres 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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