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A Randomized Controlled Study on the Effect of Supplementing Fibrinogen on Coagulation Function After Double Plasma Exchange Using Albumin as Replacement Fluid, and Its Safety and Effectiveness

A Randomized Controlled Study on the Effect of Supplementing Fibrinogen on Coagulation Function After Double Plasma Exchange Using Albumin as Replacement Fluid, and Its Safety and Effectiveness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126908
Enrollment
Unknown
Registered
2026-06-18
Start date
2026-06-20
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Blood transfusion-related side effects

Interventions

Traditional DFPP group:Received routine treatment only, without additional infusion of human fibrinogen
DFPP + Fibrinogen Group:Intravenous infusion of 2–3 g human fibrinogen immediately after DFPP treatment

Sponsors

The First Affiliated Hospital of Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age = 18 years; 2. Patients who meet the clinical indications for DFPP and are scheduled to undergo DFPP; 3. Patients scheduled to receive double filtration plasmapheresis with albumin as the replacement fluid; 4. Voluntary participation in this study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Coagulation disorders before DFPP 2. Congenital fibrinogen deficiency; 3. History of allergy to human fibrinogen; 4. Shock complicated with tissue hypoperfusion; 5. evere liver failure; 6. Systemic anticoagulation within 24 hours (heparin / low-molecular-weight heparin / aspirin / clopidogrel / ticagrelor / rivaroxaban / dabigatran / argatroban); 7. Pregnant or lactating women; 8. Active infectious diseases, such as hepatitis B, syphilis, HIV, etc.; 9. Contraindications to sodium citrate or nafamostat mesilate.

Design outcomes

Primary

MeasureTime frame
Incidence of coagulation dysfunction;

Secondary

MeasureTime frame
Incidence of filter failure;Changes in coagulation function indicators before and after treatment;Volume of blood transfusion after treatment;Changes in Sequential Organ Failure Assessment (SOFA) score;Bleeding events;Incidence of drug allergy to human fibrinogen;

Countries

China

Contacts

Public ContactMing Bai

The First Affiliated Hospital of Air Force Military Medical University

mingbai1983@126.com+86 137 7210 4001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026