Thrombosis Clinical Trial
Official title:
Inpatient Monitoring of Unfractionated Heparin
NCT number | NCT06329921 |
Other study ID # | 232192 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | May 2026 |
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.
Status | Not yet recruiting |
Enrollment | 2000 |
Est. completion date | May 2026 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Indication for anticoagulation is extracorporeal membrane oxygenation or cerebrovascular ischemic event. - Provider determines patient is not appropriate for the study. |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
Eikelboom JW, Hirsh J. Monitoring unfractionated heparin with the aPTT: time for a fresh look. Thromb Haemost. 2006 Nov;96(5):547-52. — View Citation
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. Erratum In: Chest 1999 Jun;115(6):1760. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum In: Am J Clin Pathol. 2013 Jun;141(6):899. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Measurements in therapeutic anticoagulation range | Percent of measurements in therapeutic range per coagulation assay, as defined by assay protocol | Randomization to hospital discharge at approximately 5-7 days post-randomization | |
Secondary | Coagulation laboratory measurements | The number of coagulation laboratory measurements for overall in-hospital coagulation time. | Randomization to hospital discharge at approximately 5-7 days post-randomization | |
Secondary | New thrombotic events | Incidence of new thrombotic events on anticoagulation and within 24 hours of anticoagulation cessation | Randomization to hospital discharge at approximately 5-7 days post-randomization and for 24 hours after anticoagulation cessation. | |
Secondary | New clinically relevant bleeding events | Incidence of clinically relevant bleeding adverse events (overt events or decline in hemoglobin >2 g/dL over a 24-hour period, or leading to transfusion of two or more units of whole blood or red blood cells, within 48 hours of anticoagulation cessation) | Randomization to 48 hours after anticoagulation cessation, approximately 5-7 days post-randomization | |
Secondary | New coagulation events | Incidence of new coagulation events on anticoagulation, including thrombotic events and clinically relevant bleeding adverse events as defined in Outcomes 4 and 5. | Randomization to 48 hours after anticoagulation cessation, approximately 5-7 days post-randomization |
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