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

NCT04785885 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-09-29

No results posted yet for this study

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).

Conditions

  • Transcatheter Aortic Valve Replacement
  • Cardiac Valve Annuloplasty

Interventions

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.

Sponsors & Collaborators

  • Rhode Island Hospital

    lead OTHER

Principal Investigators

  • Shyamal Asher, M.D. · Rhode Island Hospital, Brown University

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2022-03-31
Completion
2022-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04785885 on ClinicalTrials.gov