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- Ensaio Clínico NCT06329921
Monitoramento hospitalar de heparina não fracionada
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Unfractionated heparin (UFH) is the most widely used intravenous (IV) anticoagulant for the treatment and prevention of thromboembolic disease (e.g., blood clots ). When administered by intravenous injection, the onset of action is immediate. Indications for use of UFH include venous thromboembolism, acute coronary syndrome, and acute ischemic stroke. UFH is used to prevent thrombosis in the setting of arrhythmias, extracorporeal membrane oxygenation (ECMO), cardiopulmonary bypass (CPB), and endovascular procedures. The unpredictable pharmacokinetics of UFH and interpatient variability result in a narrow therapeutic index restricting its use to the hospital setting with close monitoring and adjustments.
Two validated assays exist and are in use at the VUMC adult hospital for the monitoring of unfractionated heparin: 1) the activated partial thromboplastin time (PTT) and 2) the chromogenic anti-factor Xa assay (anti-Xa). At VUMC, the PTT protocol is managed by nursing; the anti-Xa protocol is managed by clinical pharmacy. Both are clinically acceptable methods for titration and adjustment of unfractionated heparin. Assessing the therapeutic effect of unfractionated heparin is most often performed with the PTT, which requires institutional calibration to a specific heparin level to account for the variable PTT responses with different commercial reagents and laboratory instruments. The PTT can be influenced by various elements during sample processing, laboratory analysis, and patient biological factors that may cause it to be an inaccurate indication of the degree of anticoagulation. This can lead to patients not getting the correct heparin dosing for their clinical needs.
The anti-Xa assay is another method of measuring the degree of therapeutic effect of heparin. In routine clinical practice the anti-Xa is not as widely available and less familiar among many providers. This assay can be impacted by variability in sample collection and processing and laboratory analysis. Compared to the PTT assay, however, it is much less influenced by patient-specific biological factors. This may help improve heparin monitoring and titration to ensure patients receive therapeutic levels of anticoagulation and do not get too much or too little heparin. However, large studies using anti-Xa for management of heparin in the treatment of venous thromboembolism have not been performed.
PTT and anti-Xa heparin monitoring protocols have not been compared in a prospective, randomized setting. The study team will conduct a pragmatic, randomized clinical trial comparing the effectiveness of both methods for optimal monitoring of intravenous unfractionated heparin for systemic anticoagulation in hospitalized adult patients.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Active Comparator: PTT protocol
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. |
Patients will be monitored using the nurse-managed PTT protocol. |
|
Comparador Ativo: Active Comparator: anti-Xa protocol
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. |
Patients will be monitored using the pharmacy-managed anti-Xa protocol. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Time to therapeutic anticoagulation range
Prazo: Randomization to hospital discharge at approximately 5-7 days post-randomization
|
Time to reach therapeutic anticoagulation range by coagulation assay |
Randomization to hospital discharge at approximately 5-7 days post-randomization
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Measurements in therapeutic anticoagulation range
Prazo: Randomization to hospital discharge at approximately 5-7 days post-randomization
|
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
|
|
Coagulation laboratory measurements
Prazo: Randomization to hospital discharge at approximately 5-7 days post-randomization
|
The number of coagulation laboratory measurements for overall in-hospital coagulation time. |
Randomization to hospital discharge at approximately 5-7 days post-randomization
|
|
Heparin rate changes
Prazo: Randomization to hospital discharge at approximately 5-7 days post-randomization
|
Total number of heparin rate changes for overall in-hospital coagulation time |
Randomization to hospital discharge at approximately 5-7 days post-randomization
|
|
New thrombotic events
Prazo: Randomization to hospital discharge at approximately 5-7 days post-randomization and for 24 hours after anticoagulation cessation.
|
Incidence of new thrombotic events on anticoagulation or within 24 hours of anticoagulation cessation |
Randomization to hospital discharge at approximately 5-7 days post-randomization and for 24 hours after anticoagulation cessation.
|
|
New clinically relevant bleeding events
Prazo: Randomization to 48 hours after anticoagulation cessation, approximately 5-7 days post-randomization
|
Incidence of clinically relevant bleeding adverse events on anticoagulation or within 48 hours of anticoagulation cessation, defined as: fatal bleeding, or overt events causing a decline in hemoglobin >2 g/dL over a 24-hour period, or bleeding leading to transfusion of two or more units of whole blood or red blood cells, or intracranial bleeding events. |
Randomization to 48 hours after anticoagulation cessation, approximately 5-7 days post-randomization
|
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New coagulation events
Prazo: Randomization to 48 hours after anticoagulation cessation, approximately 5-7 days post-randomization
|
Incidence of new coagulation events on anticoagulation, including thrombotic events and clinically relevant bleeding adverse events as defined in Outcomes 5 and 6. |
Randomization to 48 hours after anticoagulation cessation, approximately 5-7 days post-randomization
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Benjamin Tillman, MD, Vanderbilt University Medical Center
Publicações e links úteis
Publicações Gerais
- 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.
- Eikelboom JW, Hirsh J. Monitoring unfractionated heparin with the aPTT: time for a fresh look. Thromb Haemost. 2006 Nov;96(5):547-52.
- 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.
- 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.
- 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.
- 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.
- Van Winkle G, Tillman B, Choi L, Berardi S, Dear ML, Lewis A, Rice TW; Vanderbilt Center for Learning Healthcare. Comparison of heparin assay monitoring protocols (CHAMP): study protocol for a pragmatic randomised trial. BMJ Open. 2026 Jul 29;16(7):e114634. doi: 10.1136/bmjopen-2025-114634.
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Outros números de identificação do estudo
- 232192
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.
Prazo de Compartilhamento de IPD
The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
Critérios de acesso de compartilhamento IPD
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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- ANALYTIC_CODE
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