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

Sponsor
Rhode Island Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04785885
Collaborator
(none)
40
Enrollment
1
Location
13.7
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: iStat Handheld Blood Analyzer
  • Diagnostic Test: 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 Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Clinical Onset of IV Heparin in Interventional Cardiology and Cardiac Surgery
Actual Study Start Date :
Mar 9, 2021
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Transcatheter Aortic Valve Replacement

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
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 Test: 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.
Cardiac Valve Annuloplasty

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
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 Test: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rhode Island Hospital Providence Rhode Island United States 02903

Sponsors and Collaborators

  • Rhode Island Hospital

Investigators

  • Principal Investigator: Shyamal Asher, M.D., Rhode Island Hospital, Brown University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT04785885
Other Study ID Numbers:
  • 1651774
First Posted:
Mar 8, 2021
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes

Study Results

No Results Posted as of Sep 29, 2021