Safety of Perioperative Anticoagulation Management in People With Active Cancer Undergoing Cancer-Related Surgery or Procedures (ACE-HIGH Study)

Официальное название

Active Cancer Patients Having Cancer Related Invasive Procedures or Surgery and Needing Perioperative Management of Anticoagulation Therapy (ACE-HIGH): A Prospective Management Cohort Study

Обзор

The purpose of this study is to help find how safe current practices are when managing blood thinners in people with cancer who are having surgery or medical procedures. Investigators will also measure how often bleeding or clotting problems happen in this setting. The goal is to use this information to improve future care and reduce these risks for patients. This study will determine whether contemporary practices can be safely applied to cancer patients, and also evaluate the blood thinner level left over in patient's body at the time of surgery.

Вмешательства

• Другое standardized perioperative anticoagulation management Guideline
  The intervention is implementing a standardized perioperative anticoagulation management strategy in patients with active cancer (and this strategy is consistent with guideline-directed care for patients with active cancer).

Первичные конечные точки

• Major bleeding events [Срок оценки: From enrollment to the end of study follow ups at 4 weeks"]

Вторичные конечные точки (10)

• 30-day combined risk of ATE (Arterial Thromboembolism ) /VTE (Venous Thromboembolism) [Срок оценки: 30 days]
• 30-day risk of clinically relevant non-major bleeding (ISTH definition) [Срок оценки: 30 days]
• 30-day risk of all-cause mortality [Срок оценки: 30 days]
• Time to resumption of anticoagulation (therapeutic dosing) [Срок оценки: hours from surgery to administration of therapeutic anticoagulant dose.]
• Pre-operative residual anticoagulant levels [Срок оценки: Perioperative/Periprocedural]
• Pre-operative thrombin generation assay (TGA) parameters [Срок оценки: Perioperative/Periprocedural]
• Pre-operative thrombin generation assay (TGA) parameters [Срок оценки: Perioperative/Periprocedural]
• Pre-operative thrombin generation assay (TGA) parameters [Срок оценки: Perioperative/Periprocedural]
• Pre-operative thrombin generation assay (TGA) parameters [Срок оценки: Perioperative/Periprocedural]
• Pre-operative thrombin generation assay (TGA) parameters [Срок оценки: Perioperative/Periprocedural]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Prescribed a Direct Oral Anticoagulant (DOAC), warfarin (International Normalized Ratio (INR) target 2.0-3.0) or Low Molecular Weight Heparin (LMWH) (75-100% weight-based therapeutic dosing) for stroke prevention in Atrial Fibrillation (AF) or the treatment of Venous Thromboembolism (VTE). Eligible DOAC regimens include full-dose (therapeutic) DOAC regimens appropriate for age and renal function. Eligible DOAC regimens include:

i. Apixaban 10 mg po BID (VTE) ii. Apixaban 5 mg po BID (AF or VTE) iii. Apixaban 2.5 mg po BID (AF) iv. Rivaroxaban 15 mg po BID (VTE) v. Rivaroxaban 20 mg po OD (AF or VTE) vi. Rivaroxaban 15 mg po OD (AF only) vii. Edoxaban 60 mg po OD (AF or VTE) viii. Edoxaban 30 mg po OD (AF or VTE) ix. Dabigatran 150 mg po BID (AF or VTE) x. Dabigatran 110 mg po BID (AF)

• Has active cancer, defined as:

i. cancer diagnosed within 6 months ii. recurrent, regionally advanced, or metastatic cancer iii. cancer for which treatment had been administered within 6 months before enrolment iv. hematologic cancer that is not in remission v. Patients who are felt to likely have active cancer based on clinical/imaging characteristics but are awaiting tissue confirmation and are scheduled for a biopsy procedure are eligible for trial inclusion

• Is undergoing a planned cancer-related inpatient or outpatient invasive procedure or cancer surgery (to diagnose, treat or palliate cancer; at investigator's discretion)
• Interruption of anticoagulation therapy for the planned procedure is required.

Критерии исключения

• Presence of any mechanical prosthetic heart valve
• Known pregnancy or breastfeeding
• Severe renal insufficiency (Creatinine Clearance (CrCl) < 30 mL/min or < 25 mL/min for Apixaban users)
• Condition that might impair adherence to the study protocol (e.g., cognitive impairment, geographic inaccessibility) as determined by the treating physician
• Allergy to heparin or a history of (Heparin Induced Thrombocytopenia (HIT)
• More than one surgery/procedure planned during the study period
• Previous study participation
• Inability to provide informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07372716 · ACE-HIGH 20250647-01T

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗