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A Study to Compare Response and Cost Implications Of Plasma Exchange In Renal Patients With Two Different Methods

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045959
Enrollment
24
Registered
2022-09-27
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N29- Other disorders of kidney and ureter in diseases classified elsewhere

Interventions

Intervention1: Therapeutic plasma exchange by Centrifugal Technology: To asssess plasma removal efficacy of Therapeutic plasma exchange done by Centrifugal technology, patients allocated randomly in t

Sponsors

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
a.Compare the plasma removal efficacy of centrifugal and membrane filtration technologies for TPE in nephrology patients b.Compare the Post exchange clinical, biochemical, and hematological profile in the two Groups c.Calculation of the TPE procedure costs in the two modalitiesTimepoint: recruitment 18 months results and analysis 6 months

Secondary

MeasureTime frame
Patient Outcome- Adverse events and Morbidity and mortality at 30 days and 90 days TPE cycle completionTimepoint: at 30 and 90 days post TPE cycle completion

Countries

India

Contacts

Public ContactProf RATTI RAM SHARMA

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH

div834@gmail.com9815464100

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026