An Open Label Randomized Controlled Trial To Compare Plasma Removal Efficacy As Well As Cost Of Therapeutic Plasma Exchange By Two Different Technologies (Centrifugal Vs Membranous) In Nephrology Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- a.Compare the plasma removal efficacy of centrifugal and membrane filtration technologies for TPE in nephrology patients
研究概览
简要总结
The trial will be conducted in the Department of Transfusion Medicine in collaboration with Dept. of Nephrology of the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. A convenient sample size of twenty-four patients (twelve (12) in each group) who would fulfill the inclusion criteria to be enrolled in the study after obtaining written informed consent from the study participants, the patients will be randomized into either of the two study arms.
Group I: Patient who undergo Therapeutic plasma exchange by centrifugal technique (cTPE) after informed consent
Group II: Patient who undergo Therapeutic plasma exchange by membranous technique (mTPE) after informed consent
Baseline investigations and clinical details of the patients will be recorded and patients counselled by the clinician for the available therapies and randomly allocated into cTPE or mTPE group for assessing the efficacy of plasma removal by therapeutic plasma exchange as well cost involved in the procedures being done.
Primary and Secondary outcomes would be studied in the study participants and results evaluated when available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.No evidence of active infection 2.Willing to give informed consent for the procedure (In patients who are incompetent to consent, consent shall be taken from the surrogate) 3.Those who not enrolled in any other study.
排除标准
- •1.Pregnancy 2.Microbiological or radiological evidence of active infection 3.Known allergy to Plasma, Protamine or Heparin.
- •4.Severe systemic illness like HIV 5.Patients with vasculitis due to secondary causes (diagnosis of a different rheumatic disease, Hepatitis B, Hepatitis C, HIV infection) 6.Mechanically ventilated patients 7.Renal or any other Transplant recipient will be excluded.
结局指标
主要结局
a.Compare the plasma removal efficacy of centrifugal and membrane filtration technologies for TPE in nephrology patients
时间窗: recruitment 18 | months | results and | analysis 6 months
b.Compare the Post exchange clinical, biochemical, and hematological profile in the two
时间窗: recruitment 18 | months | results and | analysis 6 months
Groups
时间窗: recruitment 18 | months | results and | analysis 6 months
c.Calculation of the TPE procedure costs in the two modalities
时间窗: recruitment 18 | months | results and | analysis 6 months
次要结局
- Patient Outcome- Adverse events and Morbidity and mortality at 30 days and 90 days TPE cycle completion(at 30 and 90 days post TPE cycle completion)