Skip to content

Safety and efficacy of RCA in combination with arginine hydrochloride in plasma exchange:an prospective, randomized, controlled, double-blind clinical study

Safety and efficacy of RCA in combination with arginine hydrochloride in plasma exchange:an prospective, randomized, controlled, double-blind clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066139
Enrollment
Unknown
Registered
2022-11-25
Start date
2022-12-01
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

Plasma exchange

Interventions

The treatment group:RCA combined with arginine hydrochloride in plasma exchange
The control group:RCA combined with placebo

Sponsors

The Medical Ethics Committee of the First Affiliated Hospital of the Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; 2. Plasma was used as replacement fluid for plasma exchange therapy; 3. Plasma exchange was performed with RCA; 4. Willing to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe liver insufficiency (Child-Pugh score > 10 (chronic severe liver failure), MELD score > 30(acute severe liver failure), total bilirubin > 51 mu mol/L); 2. Shock with muscle hypoperfusion (serum lactic acid > 2mmol/L; Prolonged capillary refill time, skin spots or ecchymosis; Blood pressure 7.45, HCO3- > 27mmol/L); 5. The presence of infectious diseases such as hepatitis B, syphilis, HIV, etc.;

Design outcomes

Primary

MeasureTime frame
Efficacy end point of plasmapheresis: Successful completion of the treatment process;Acid-base disorders end point : Metabolic alkalosis/Severe alkalosis;

Secondary

MeasureTime frame
Anticoagulation-related complications;Adverse events of arginine hydrochloride drugs;Indicators of changes associated with the disease;Parameters of plasma exchange;

Countries

China

Contacts

Public ContactMing Bai

The First Affiliated Hospital of the Air Force Medical University

mingbai1983@126.com+86 137 7210 4001

Outcome results

None listed

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