Prolonged Hypercoagulability Following Major Liver Resection for Malignancy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number pf participants with hypercoagulability identified via TEG testing
研究概览
简要总结
This clinical trial will investigate the ability of thromboelastrogrpahy (TEG®) to detect hypercoagulability after liver surgery and will examine the effect of extended thromboprophylaxis (medical treatment to prevent the development of blood clots inside blood vessels) in patients undergoing liver surgery for cancer treatment.
The liver plays a key role in regulating the process of blood clotting. As a result, blood clots are a major cause of complications and death following liver surgery. This is especially true in cancer patients who are at a higher risk of developing blood clots. Current methods for preventing clotting complications after liver surgery include conventional coagulation blood tests (CCTs) and anticoagulant drugs, such as low molecular weight heparins (LMWHs). Current LMWH treatment is prescribed for one month after surgery, but studies show that the risk of developing blood clots can last up to 3 months. Studies also show that CCTs may not be as effective in detecting clotting issues as more comprehensive testing systems, such as TEG. This study will randomize 50 participants to receive 90 days of thromboprophylaxis (using the LMWH Redesca) or the standard of care 30 days (using the LMWH Fragmin) after liver surgery. The medication will be given by injection, similar to a regular vaccine or an insulin injection. Participants will inject the medication every day, for 30 or 90 days, after surgery. Participants will also have their blood tested for clotting issues via TEG testing before surgery and on post-operative days 1,3,5,30 and 90. After surgery, participants will be monitored by their surgeon for clotting complications and 3 year disease-free survival.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older at the time of enrollment.
- •Requiring major liver resection (>2 liver sections) for any oncologic indication.
- •Requiring postoperative thromboprophylaxis will be included.
- •Willing and able to perform subcutaneous injections according to the study protocol, or receive injections form a caregiver delegated by the participant.
排除标准
- •Anyone below 18 years of age.
- •Patients on current anticoagulant and/or antiplatelet therapy
- •Patients with a history of thrombotic events
- •Patients with a coagulation disorder.
- •Patients with recognized thrombophilia.
- •Patients who cannot understand/speak or read in English.
研究组 & 干预措施
Redesca
Patients in the extended thromboprophylaxis group will receive Redesca (enoxaparin sodium for injection) (40mg) once a day, starting on the day of surgery, for 90 days postoperatively.
干预措施: Redesca (enoxaparin sodium for injection) (Drug)
Fragmin
Patients in the standard of care group will receive Fragmin (daletparin) (5,000 I.U) once a day, starting on the day or surgery, for 30 days postoperatively.
干预措施: Fragmin (dalteparin) (Drug)
结局指标
主要结局
Number pf participants with hypercoagulability identified via TEG testing
时间窗: Preoperatively (with pre-admission blood work) through to 90 days postoperatively
All participants will have postoperative TEG testing performed for the detection of hypercoagulability.
次要结局
- Thrombotic Events(Up to 6 months postoperatively)
- Disease Free Survival(Up to 3 years postoperatively)