CPI Combination Therapy for Autoimmune Encephalitis

NACompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

November 25, 2020

Primary Completion Date

December 12, 2022

Study Completion Date

September 12, 2024

Conditions
Autoimmune Encephalitis
Interventions
PROCEDURE

Plasma exchange (PE)

PE is performed every other day using a multi-filtrate apheresis device (Fresenius, Bad Homburg, Germany), and 5 times in total for each course. The plasma removed during PE is replaced with an equal volume of substitution (half 5% albumin with normal saline and half plasma). The plasma volume to be replaced was estimated according to the following formula: plasma volume (L) = 7.5%×weight (kg)×(1-hematocrit)×1000ml. Heparin was added to the exchange circuit to prevent blood clotting. The exchange rate was monitored, recorded, and balanced to prevent cardiovascular instability. Blood pressure and other vital signs were closely monitored every 15 minutes throughout the exchange.

DRUG

intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP)

IVIG is given 0.4 g/kg/d for each course for 5 days. IVMP is 1,000 mg or 500 mg methylprednisolone for 3 or 5 days, and the dosage of glucocorticoid will gradually decrease.

Trial Locations (1)

100053

Xuanwu Hospital of Capital Medical University, Beijing

All Listed Sponsors
lead

Xuanwu Hospital, Beijing

OTHER

NCT03542279 - CPI Combination Therapy for Autoimmune Encephalitis | Biotech Hunter | Biotech Hunter