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Prospective cohort study on the safety and effectiveness of SURGICEL hemostatic accumulation granules in acute pancreatitis surgery

Prospective cohort study on the safety and effectiveness of SURGICEL hemostatic accumulation granules in acute pancreatitis surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114187
Enrollment
Unknown
Registered
2025-12-09
Start date
2025-12-10
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Surgery for Severe Pancreatitis

Interventions

SURGICEL hemostatic granules group:None
ARISTA hemostasis powder group:None

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnosis of acute pancreatitis/pancreatitis necrosis and need surgical treatment; 2. Aged 18-74 years; 3. Patients with SBSS bleeding score of grade 3 or below; 4. Provide signed and dated informed consent.

Exclusion criteria

Exclusion criteria: 1. Coagulation insufficiency: Patients with blood system diseases (such as hemophilia), severe liver and kidney dysfunction (Child classification C for liver function), prothrombin time (PT)>18 seconds or activated partial thromboplastin time (APTT)>52 seconds; 2. Pregnant or lactating women; 3. Patients who have recently participated in other clinical trials; 4. Subjects who took heparin 12 hours before the operation or took coumarin (warfarin) and/or X-a factor inhibitors orally within 3 days before the operation; Subjects who received antiplatelet /P2Y12 inhibitor drug treatment within 5 days before the operation.

Design outcomes

Primary

MeasureTime frame
The success rate of hemostasis on the flat wound was 3 minutes;

Secondary

MeasureTime frame
The success rate of hemostasis on the flat wound was 5 minutes;The success rate of hemostasis on flat wound in 10 minutes;Hemostatic time [Hemostatic time for the product];The amount of wound bleeding;Total operative time;The proportion of intraoperative lens blur;Postoperative Blood Transfusion Volume(Within 3 days after surgery);Postoperative Blood transfusion Volume (within 3 days);Change in Hemoglobin (Hb);Postoperative Drainage Volume (Within 3 Days After Surgery);Postoperative Drainage Duration;Rate of Reoperation(Within 3 Days After Surgery);Rate of Moderate to Severe Bleeding-Related Adverse Reactions(Up to Discharge);Cost of Hemostatic Materials;Usage Quantity of Hemostatic Materials (Vial(s));Hospitalization Costs;Postoperative Hospitalization Time;Hospitalization Time;

Countries

China

Contacts

Public ContactLu Huimin

West China Hospital of Sichuan University

hm.lu@scu.edu.cn+86 189 8060 5201

Outcome results

None listed

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