Low molecular weight heparin in treatment of moderately severe and severe acute pancreatitis; A randomized control trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Pancreatic Necrosis
研究概览
简要总结
This is a single centre, hospital based, randomised control trial todetermine the effect of low molecular weight heparin (enoxaparin) on outcome ofmoderately severe and severe acute pancreatitis. Study period was two years. Patientsof acute pancreatitis meeting the selection criteria were randomized to controlgroup and trial group with 70 patients in each group. Control group receivesconventional treatment for acute pancreatitis and control group receivedenoxaparin 1mg/kg body weight in addition to the conventional treatment for 7days. CT scans were done on day0 and day8 of the treatment and otherinvestigations were done as per standard protocol. Data was recorded insystematic proforma and the outcomes of both the groups are compared. theprimary outcome was pancreatic necrosis and secondary outcomes compared wereclinical wellbeing, local and systemic complications, need for interventionsand mortality during the current episode of acute pancreatitis. Use of LMWH in early stage of moderately-severe andsevere acute pancreatitis had significant positive impact on all the parametersthat were assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of moderately severe or severe acute pancreatitis.
- •Admitted within 24hours of onset of symptoms.
- •willing to participate.
排除标准
- •Chronic pancreatitis.
- •Traumatic pancreatitis.
- •Hypersensitivity to low molecular weight heparin, heparin, pork products, benzyl alcohol or other ingredients of enoxaparin preparation or radio contrast agent.
- •Any contraindication for low molecular weight heparin.
- •Pregnancy and lactation.
- •Charlson Comorbidity Index 5 or more.
结局指标
主要结局
Pancreatic Necrosis
时间窗: Baseline and at the end of one week of treatment
次要结局
- Local and systemic complications(During the period of current episode of acute pancreatitis)
- Clinical wellbeing(time taken to tolerate oral feeds, time of relief from abdominal symptoms and signs, mean duration of hospital stay)(During the period of current episode of acute pancreatitis)
- Need for surgical, endoscopic or minimal invasive procedure(During the period of current episode of acute pancreatitis)
- Mortality(During the period of current episode of acute pancreatitis)