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Comparison of the efficacy and safety of nafamostat mesylate and heparin in blood purification therapy for patients with severe acute pancreatitis: A randomized controlled trial

Comparison of the efficacy and safety of nafamostat mesylate and heparin in blood purification therapy for patients with severe acute pancreatitis: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111161
Enrollment
Unknown
Registered
2025-10-27
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Severe acute pancreatitis

Interventions

NM group:nafamostat mesylate
H group:Heparin pump for anticoagulation

Sponsors

Weifang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) adults over 18 years old, (2) diagnosed with severe acute pancreatitis (SAP) according to the revised Atlanta classification (2012), meeting at least one of the following: Persistent organ failure (>48 hours), or APACHE II score >=8 or SOFA score >=4 at ICU admission, (3) requiring blood purification therapy (continuous renal replacement therapy [CRRT] or hemoperfusion) due to systemic inflammatory response, acute kidney injury, or hypercytokinemia, (4) informed consent obtained from patient or surrogate.

Exclusion criteria

Exclusion criteria: (1) known hypersensitivity or contraindication to NM or UFH, (2) severe coagulation disorders (INR >2.0), active major bleeding (such as intracranial hemorrhage, ongoing gastrointestinal bleeding) or recent uncontrolled bleeding and bleeding diseases or platelet count <30×10?/L, (3) severe hepatic failure (Child–Pugh C) , (4) History of heparin-induced thrombocytopenia (HIT), (5) pregnancy or lactation. (6) chronic kidney disease requiring dialysis before ICU admission, (7) expected survival <48 hours or refusal to participate.

Design outcomes

Primary

MeasureTime frame
average service life of the blood purification circuit or filter.;

Secondary

MeasureTime frame
SOFA and APACHE II changes from the baseline ;Changes in PCT, CRP, IL-6, IL-10 and TNF-a;

Countries

China

Contacts

Public ContactGao Zhipeng

Weifang People's Hospital

gao4219157@163.com+86 159 6341 2895

Outcome results

None listed

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