Evaluation of Effectiveness of Fresh Frozen Plasma Transfusion as a Novel Adjuvant Treatment in Acute Organophosphate Poisoned Patients. A Randomized Clinical Trial in Poison Control Center Ain Shams University Hospital.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- mortality rate
研究概览
简要总结
this study clinical trial to assess the role of fresh frozen plasma as a novel available and easy to be applied rather than conventional therapy on organophosphate poisoned patients and prediction of it is prognosis on selected patients and it is effect on outcome .
详细描述
a prospective randomized clinical trail study . this study will be conducted in poison control center Ain shas university hospital -Egypt . all adult patients of both sexes admitted , in Poison Control Center of Ain Shams University Hospitals (PCC-ASUH) with diagnosis of moderate and severe degree of organophosphate poisoning will be included in this study.
The severity of patients under the study will be assessed at the time of presentation using the PeradeniyaOrganophosphorus Poisoning (POP) scale The severity will be graded as mild(0-3), moderate (4-7), and sever (8- 11).
The included patients in this study will be randomly divided into two groups as follow:
Group A: Patients who will be treated according to traditional management protocol of OPC toxicity in the form of: supportive measures, decontamination and antidotal therapy (atropine &Oximes) as follow:
- Supportive measures and patients resuscitation.
- Decontamination: patients presenting within 4hr of OP ingestion will be subjected to gastric lavage and all patients with oral exposure will be given a single (30 mg) dose of activated charcoal. Any contaminated material will be discarded and dermal contamination will be carried out using soap and water,if necessary.
- Antidotal therapy: Atropine(each ampoule contains 1mg of atropine per ml) will be given as bolus doses of 2-5 mg IV and repeated every10-15 min until dryness of chest secretions, and then atropine injections maintenance doses will be given intermittently to patients as needed .Toxogonin (each ampoule contains 250mg of obidoxime chloride in 1 ml, produced by Merck, Darmstadt, Germany)will be administered as a loading dose of 250 mg, and will be repeated every 8 hrs until at least 12hrs after atropine no longer required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate and severe degree of organophosphate poisoning will be included in this study.
排除标准
- •patients below 18 years or above 60 years.
- •Patients with history of diabetes, cardiac disease, respiratory, renal disease and hepatic disease.
- •Pregnant female
- •Patients suspected of having mixed or unknown exposure
- •Patients with coagulation disorders.
- •Patients with hyper sensitivity to FFP or plasma derived products, as these cases are contraindicated to take fresh frozen plasma
结局指标
主要结局
mortality rate
时间窗: 3 monthes
fresh frozen plasma decrease the mortality rate among organophosphate poisoned patients
次要结局
未报告次要终点
