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

NCT04785885 | Unknown FDA Device

• 1 other identifier: 1651774
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Transcatheter Aortic Valve Replacement; Cardiac Valve Annuloplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Laboratory-based anticoagulation

  Baseline, 30 seconds and 180 seconds after IV heparin administration

Study Arms (2)

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; Diagnostic Test: Hemochron

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; Diagnostic Test: Hemochron

Interventions

iStat Handheld Blood Analyzer DIAGNOSTIC_TEST

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; Transcatheter Aortic Valve Replacement

Hemochron DIAGNOSTIC_TEST

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; Transcatheter Aortic Valve Replacement

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult cardiac surgical patients with intravenous (IV) administration of unfractionated heparin.

You may qualify if:

• Adult cardiac surgery patients presenting for elective valvular surgery
• Interventional cardiology patients presenting elective Transcatheter Aortic Valve Replacement (TAVR)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 32620484 BACKGROUND

• 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.

  PMID: 28359133 BACKGROUND

• 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.

  PMID: 11375810 BACKGROUND

Study Officials

• Shyamal Asher, M.D.

  Rhode Island Hospital, Brown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shyamal Asher, M.D.

CONTACT

(401) 444-5172; sasher@lifespan.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: March 9, 2021
• Primary Completion: March 31, 2022
• Study Completion: April 30, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)