Anti-Xa Guided Dosing of Low Molecular Weight Heparin for Prevention of Venous Thromboembolism Following Traumatic Injury: a Multicentre Pilot Randomized Trial

Обзор

This multicentre pilot trial will assess the feasibility of a full-scale, randomized trial to determine whether bloodwork guided dosing of blood thinners reduces the risk of clotting in high-risk trauma patients. Patients will receive either standard of care dosing or dosing with adjustments based on bloodwork to achieve a minimum therapeutic threshold.

Подробное описание

This multicentre pilot trial will assess the feasibility of a full-scale, randomized trial to determine whether anti-Xa guided dosing of low molecular heparin (LMWH) reduces the risk of venous thromboembolism (VTE) in high-risk trauma patients. Patients will receive either standard of care fixed dosing of Enoxaparin or 0.5 mg/kg twice daily with dose adjustments to achieve an anti-Xa trough level between 0.1 and 0.2 IU/mL.

Вмешательства

• Препарат Anti-Xa Guided Dosing of Low Molecular Weight Heparin
  Participants will receive Enoxaparin 0.5 mg/kg twice daily (rounded up or down to the nearest 10 mg) the initial starting dose. Dose adjustments will be made based on trough levels drawn between the 3rd and 4th dose. The target anti-Xa level range is between 0.1 and 0.2 IU/mL. If the patient is below the target range, then the next Enoxaparin dose will be increased by 10 mg per dose with a new trough anti-Xa level 24 hours after dose modification. If the patient is above the target range, then t
• Препарат Standard of Care Dosing
  Participants will receive Enoxaparin dosed at the discretion of the most responsible physician (MRP). In cases of severe renal insufficiency (CrCl \< 30mL/min\^:), the LMWH may dose reduced or changed to Heparin at the discretion of the MRP.

Первичные конечные точки

• Recruitment (Patients per site per month) [Срок оценки: Participants per site per month x 15 months]

Вторичные конечные точки (9)

• Eligibility rate [Срок оценки: 15 months]
• Consent rate [Срок оценки: 15 months]
• Retention rate [Срок оценки: 15 months]
• Study completion rate [Срок оценки: 15 months]
• Adherence rate [Срок оценки: 15 months]
• Adherence to monitoring [Срок оценки: 15 months]
• Adherence to dose adjustment [Срок оценки: 15 months]
• Adherence to anti-Xa target [Срок оценки: 15 months]
• Reasons for declining participation [Срок оценки: 15 months]

Критерии участия

Критерии включения

• Patients 18 years of age or older admitted to a hospital ward or intensive care unit following a traumatic injury involving two or more body systems (head, chest, abdomen, pelvis, extremity) and meeting at least one of the following high-risk criteria previously identified in a recent systematic review (1): age ≥ 65, body mass index ≥ 30 kg/m2, injury severity score ≥ 16, pelvic injury with activity restrictions, lower extremity injury with activity restrictions, or surgery during the index hospitalization.

To be eligible, patients must be deemed appropriate for pharmacologic prophylaxis by the most responsible physician and randomized with the intention to receive prophylaxis within 48 hours of admission. Prior to randomization, there is no restriction on whether or not patients have previously received pharmacologic or mechanical prophylaxis.

Критерии исключения

• Greater than 7 days since time of injury.
• Requirement for therapeutic anticoagulation or dual-antiplatelet therapy
• Unable or unwilling to receive pharmacologic prophylaxis within 48 hours of admission.
• History of allergic reaction or sensitivity to LMWH.
• Thrombocytopenia with platelets \< 30.
• Expected discharge or transfer from hospital within 72 hours.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06662253 · 20240579-01H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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