Inpatient Monitoring of Unfractionated Heparin

NCT06329921 | Enrolling By Invitation DMC

• 1 other identifier: 232192
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

Unfractionated heparin (UFH) is the most widely used intravenous (IV) anticoagulant for treating and preventing thromboembolic disease (e.g., blood clots ). UFH must be closely monitored and adjusted in the hospital. There are two assays used to monitor UFH: 1) the activated partial thromboplastin time (PTT) and 2) the chromogenic anti-factor Xa assay (anti-Xa). This study aims to compare PTT and anti-Xa methods for monitoring UFH in a pragmatic, randomized controlled trial to determine which helps patients reach a therapeutic anticoagulation range faster.

Conditions

Blood Clot; Thrombosis

Keywords

heparin; anticoagulation; anti-Xa; PTT

Outcome Measures

Primary Outcomes (1)

• Time to therapeutic anticoagulation range

  Time to reach therapeutic anticoagulation range by coagulation assay

  Randomization to hospital discharge at approximately 5-7 days post-randomization

Secondary Outcomes (6)

• Measurements in therapeutic anticoagulation range

  Randomization to hospital discharge at approximately 5-7 days post-randomization

• Coagulation laboratory measurements

  Randomization to hospital discharge at approximately 5-7 days post-randomization

• Heparin rate changes

  Randomization to hospital discharge at approximately 5-7 days post-randomization

• New thrombotic events

  Randomization to hospital discharge at approximately 5-7 days post-randomization and for 24 hours after anticoagulation cessation.

• New clinically relevant bleeding events

  Randomization to 24 hours after anticoagulation cessation, approximately 5-7 days post-randomization

Study Arms (2)

Active Comparator: PTT protocol

ACTIVE COMPARATOR

Patients randomized to this arm will be monitored using the nurse-managed PTT guided protocol. This includes patients on both high- and low-dose heparin protocols.

Other: PTT protocol

Active Comparator: anti-Xa protocol

ACTIVE COMPARATOR

Patients randomized to this arm will be monitored using the pharmacy-managed anti-Xa protocol. This includes patients on both high- and low-dose heparin protocols.

Other: anti-Xa protocol

Interventions

PTT protocol OTHER

Patients will be monitored using the nurse-managed PTT protocol.

Active Comparator: PTT protocol

anti-Xa protocol OTHER

Patients will be monitored using the pharmacy-managed anti-Xa protocol.

Active Comparator: anti-Xa protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at Vanderbilt University Hospital age 18 years and older who are admitted as observation or inpatients for whom intravenous unfractionated heparin (monitored via the PTT nurse-managed protocol) is ordered.
• Baseline PTT value is ≥0 and ≤ 36.0 seconds
• Baseline heparin level anti-Xa assay value is ≥0 and ≤0.3

You may not qualify if:

• Indication for anticoagulation is extracorporeal membrane oxygenation or cerebrovascular ischemic event.
• Provider determines patient is not appropriate for the study.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (6)

• Hirsh J, Warkentin TE, Raschke R, Granger C, Ohman EM, Dalen JE. Heparin and low-molecular-weight heparin: mechanisms of action, pharmacokinetics, dosing considerations, monitoring, efficacy, and safety. Chest. 1998 Nov;114(5 Suppl):489S-510S. doi: 10.1378/chest.114.5_supplement.489s. No abstract available.

  PMID: 9822059 BACKGROUND

• Smythe MA, Priziola J, Dobesh PP, Wirth D, Cuker A, Wittkowsky AK. Guidance for the practical management of the heparin anticoagulants in the treatment of venous thromboembolism. J Thromb Thrombolysis. 2016 Jan;41(1):165-86. doi: 10.1007/s11239-015-1315-2.

  PMID: 26780745 BACKGROUND

• Eikelboom JW, Hirsh J. Monitoring unfractionated heparin with the aPTT: time for a fresh look. Thromb Haemost. 2006 Nov;96(5):547-52.

  PMID: 17080209 BACKGROUND

• Olson JD, Arkin CF, Brandt JT, Cunningham MT, Giles A, Koepke JA, Witte DL. College of American Pathologists Conference XXXI on laboratory monitoring of anticoagulant therapy: laboratory monitoring of unfractionated heparin therapy. Arch Pathol Lab Med. 1998 Sep;122(9):782-98.

  PMID: 9740136 BACKGROUND

• Wool GD, Lu CM; Education Committee of the Academy of Clinical Laboratory Physicians and Scientists. Pathology consultation on anticoagulation monitoring: factor X-related assays. Am J Clin Pathol. 2013 Nov;140(5):623-34. doi: 10.1309/AJCPR3JTOK7NKDBJ.

  PMID: 24124140 BACKGROUND

• Marlar RA, Clement B, Gausman J. Activated Partial Thromboplastin Time Monitoring of Unfractionated Heparin Therapy: Issues and Recommendations. Semin Thromb Hemost. 2017 Apr;43(3):253-260. doi: 10.1055/s-0036-1581128. Epub 2016 Jun 6.

  PMID: 27272964 BACKGROUND

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Benjamin Tillman, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will be performed as a pragmatic, randomized controlled clinical trial with parallel group assignment.

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: June 26, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.

Locations

US (1)