Efficacy of Prophylactic use of Apixaban vs Aspirin Following Laparoscopic Splenectomy in Patients with risk of Portal Vein thrombosis: A Phase 2 Randomised Control Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Proportion of Patients who develop Portal venous thrombosis after Laparoscopic Splenectomy in Apixaban group vs Aspirin group.
研究概览
简要总结
Portal vein thrombosis (PVT) is a common and potentially life-threatening complication following a splenectomy. It can lead to liver function damage, intestinal ischemia, portal hypertension, an increased risk of variceal bleeds, cavernoma formation, portal biliopathy, and even death.
The incidence of PVT following post-splenectomy varies widely from 5% to 52% in the literature.The American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) recommend considering prophylactic anticoagulation in high-risk patients undergoing splenectomy. However, the optimally recognised anticoagulation regimen remains debated to date.
Studies reported that prophylactic anticoagulation in the postoperative period significantly reduced the risk of portal venous thrombosis. Hence, identifying these patients at risk of portal venous thrombosis prior to surgery will help optimize anticoagulation in the postoperative period.
From the available literature, there have been reports of the beneficial role of low molecular weight heparin (LMWH) as a prophylactic anticoagulant in high-risk patients undergoing splenectomy.Studies confirm that, compared with conventional anticoagulants, Apixaban is safer for the general population.Apixaban has not yet been used as a prophylactic agent to prevent PVT after splenectomy. It has been used for the treatment of acute and chronic PVT.
Studies show that Apixaban is as effective as traditional anticoagulants such as LMWH and Warfarin for the treatment of portal vein thrombosis in both cirrhotics and non-cirrhotics, with fewer bleeding complications.Apixaban has a relatively wide therapeutic window, a safety profile, a user-friendly fixed-dose regimen without the need to monitor the PT, with fewer food and drug interactions compared with other anticoagulants, and a reduced cost.There is no randomised control trial in the English literature to compare the efficacy of prophylactic Apixaban compared to Aspirin in post-splenectomy patients with thrombotic risk to prevent PVT. Therefore, a study to find the role of prophylactic use of Apixaban in post-splenectomy patients with the primary endpoint of PVT prevention is warranted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •It is indicated for laparoscopic splenectomy.
- •Any of the Risk Factors of Portal Venous Thrombosis in Splenomegaly that is Pre-operative Portal Vein diameter greater than 10 mm.
- •Post-splenectomy Splenic weight greater than 1000 gm Spleen span on USG is more than 15 cm Willing to provide informed consent.
排除标准
- •Refusal to consent Evidence of PVT prior to the surgery.
- •Known thrombophilia.
- •Chronic kidney disease (creatinine clearance less than 30 mL/min).
- •Chronic liver disease, or cirrhotic liver,.
- •Recent use of other anticoagulants or thrombolytics.
- •Active peptic ulcer disease.
- •History of major bleeding events or bleeding disorders.
- •Active or recent gastrointestinal bleeding.
- •Pregnant or breastfeeding women.
- •Concurrent use of medications contraindicated with apixaban.
- •Non-compliance to medicine during follow-up Allergic to Apixaban/Aspirin.
- •Cognitive impairment or psychiatric illness.
结局指标
主要结局
Proportion of Patients who develop Portal venous thrombosis after Laparoscopic Splenectomy in Apixaban group vs Aspirin group.
时间窗: 3 Months from the day of surgery
次要结局
- Bleeding with or without requiring transfusion.(3 months from the day of surgery)
- Difference in Portal vein velocity post-surgery.(3 months from the day of surgery.)
- Postoperative Liver Function-Assessed via liver function tests (LFTs), including ALT, AST, bilirubin, and albumin levels.(3 months from the day of surgery)
- Occurrence of other thromboembolic events, such as deep vein thrombosis or pulmonary embolism.(3 months from the day of surgery)
- Direct cost analysis between the groups.(3 months from the day of surgery)
- Mortality Rate: Deaths occurring within 3 months post-surgery.(3 months from the day of surgery)
研究者
Dr Saksham Gagal
All Indian Institute of Medical Sciences,New Delhi