The Laboratory Effect of Rivaroxaban Compared to Enoxaparin as Prophylactic Anticoagulant Therapy After Cesarean Section: A Randomized Open-Label Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Endogenous Thrombin Potential (ETP)
研究概览
简要总结
Pregnancy and the postpartum period increase venous thromboembolism (VTE) risk. After cesarean section, low-molecular-weight heparin (LMWH; enoxaparin) is commonly used for short-term thromboprophylaxis, but it requires daily subcutaneous injections and can cause adverse effects. Direct oral anticoagulants (DOACs) such as rivaroxaban offer convenient once-daily oral dosing. In women who meet institutional criteria for short-term postpartum thromboprophylaxis until hospital discharge, we will compare the laboratory anticoagulant effect of rivaroxaban versus enoxaparin using thrombin generation parameters.
This randomized, open-label trial will enroll women undergoing elective cesarean section who are indicated for in-hospital prophylaxis. Blood will be drawn on postoperative day 2 at trough (pre-dose) and peak (~3 hours post-dose) to measure thrombin generation, anti-Xa activity and drug levels, and participants will complete the Anti-Clot Treatment Scale (ACTS) satisfaction questionnaire. Safety follow-up will occur by telephone at 2 days post-discharge and at 6 weeks postpartum.
详细描述
Randomized (1:1), open-label, parallel-group, single-center study at Wolfson Medical Center. Eligible participants (Hebrew-speaking, age 18-50, elective cesarean, and meeting local VTE prophylaxis criteria) are randomized to rivaroxaban 10 mg PO once daily or enoxaparin 40 mg SC once daily from the day of surgery until discharge (first dose ≥12 h after cesarean and ≥6 h after spinal anesthesia). On POD2 two blood draws are performed: trough pre-dose and peak ~3 h after dosing. Tests: PT, aPTT, anti-Xa with appropriate calibrators, thrombin generation (endogenous thrombin potential [ETP], lag time, peak thrombin). ACTS (Anti-Clot Treatment Scale (ACTS) satisfaction questionnaire) is administered before discharge. Safety follow-up calls 2 days after discharge and 6 weeks postpartum for bleeding, VTE, allergic reactions or other AEs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hebrew-speaking women
- •age 18-50
- •Elective cesarean at Wolfson
- •Indicated for in-hospital thromboprophylaxis per local protocol (need ≥2 risk factors among: cesarean delivery; age >35; BMI >30; parity ≥3; labor duration ≥12 h; postpartum hemorrhage or blood transfusion; reduced mobility)
排除标准
- •Known thrombophilia
- •Prior arterial/venous thrombosis
- •Creatinine clearance <29 mL/min
- •Abnormal liver enzymes/bilirubin or liver disease
- •Coagulation disorders
- •Platelets <75,000/mm³
- •Interacting drugs affecting DOAC metabolism (e.g., strong CYP3A4/P-gp modulators; azoles; protease inhibitors; rifampicin; phenytoin; carbamazepine; phenobarbital; St. John's wort; dronedarone)
- •Active bleeding or contraindication to anticoagulation
- •Peptic disease/GI bleeding history
- •Hemoptysis risk/history
- •Preeclampsia
- •Active infection
- •Significant lower-limb varicosities
- •Need for prophylaxis beyond discharge (≥3 risk factors)
- •Maternal weight <50 kg or >100 kg
研究组 & 干预措施
Enoxaparin
Participants receive enoxaparin 40 mg subcutaneously (SC) once daily, starting ≥12 hours after cesarean delivery and ≥6 hours after spinal anesthesia, and continuing once daily during the index hospitalization until discharge. Standard postpartum care is provided to all participants
干预措施: Enoxaparin 40 mg (Drug)
Rivaroxaban
Participants receive rivaroxaban 10 mg orally (PO) once daily, starting ≥12 hours after cesarean delivery and ≥6 hours after spinal anesthesia, and continuing once daily during the index hospitalization until discharge. Standard postpartum care is provided to all participants.
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Endogenous Thrombin Potential (ETP)
时间窗: Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization
Between-group comparison of ETP to assess similarity of anticoagulant effect; lower ETP indicates greater anticoagulation.
次要结局
- Thrombin Generation - Lag Time (minutes)(Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization)
- Thrombin Generation - Peak Thrombin (nM)(Postoperative day 2: immediately before the study drug dose (trough) and approximately 3 hours after the study drug dose (peak), during the index hospitalization)
- Anti-Xa activity (IU/mL) - Enoxaparin arm(Postoperative day 2: immediately before the enoxaparin dose (trough) and approximately 3 hours after the enoxaparin dose (peak), during the index hospitalization)
- Plasma Rivaroxaban Concentration (ng/mL) - Rivaroxaban arm(Postoperative day 2: immediately before the rivaroxaban dose (trough) and approximately 3 hours after the rivaroxaban dose (peak), during the index hospitalization)
- Treatment Satisfaction (ACTS Questionnaire total and subscales)(Postoperative day 2, prior to hospital discharge)
- Adverse Events (bleeding and VTE)(From randomization through 6 weeks postpartum, including assessment during the index hospitalization, approximately 2 days after discharge, and at 6 weeks postpartum)
研究者
Hagit Eisenberg
Obstetrics and Gynecology Resident Physician
Wolfson Medical Center