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

• Conditions: Transcatheter Aortic Valve Replacement; Cardiac Valve Annuloplasty
• Interventions: Diagnostic Test: iStat Handheld Blood Analyzer; Diagnostic Test: Hemochron

• Registration Number: NCT04785885
• Lead Sponsor: Rhode Island Hospital

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.

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-08
• Study Start: 2021-03-09
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29
• Primary Completion: 2022-03-31
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transcatheter Aortic Valve Replacement	Hemochron	Patients receive 100U/Kg of IV heparin. An arterial sample activated clotting time (ACT) will be checked by iStat and hemochron
Cardiac Valve Annuloplasty	iStat Handheld Blood Analyzer	Patients receive 300U/kg of IV heparin. An arterial sample activated clotting time (ACT) will be checked by iStat and hemochron
Cardiac Valve Annuloplasty	Hemochron	Patients receive 300U/kg of IV heparin. An arterial sample activated clotting time (ACT) will be checked by iStat and hemochron
Transcatheter Aortic Valve Replacement	iStat Handheld Blood Analyzer	Patients receive 100U/Kg of IV heparin. An arterial sample activated clotting time (ACT) will be checked by iStat and hemochron

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States