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Clinical trial for the safety and efficacy of compound macroporous polypolysaccharide absorbable hemostatic materials for intraoperative hemostasis

Clinical trial for the safety and efficacy of compound macroporous polypolysaccharide absorbable hemostatic materials for intraoperative hemostasis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024464
Enrollment
Unknown
Registered
2019-07-12
Start date
2019-12-23
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

intraoperative bleeding

Interventions

Experimental group:Using compound macroporous polypolysaccharide absorbable hemostatic materials
Control group:Using other hemostatic materials

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) aged 18 to 70 years old male and female; 2) patients requiring elective surgery; 3) the severity of bleeding on the target wound; 4) patients or their legal representatives can understand the purpose of the study, show adequate compliance with the study protocol, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) the proposed surgical site for III, IV surgical incision; 2) patients with poorly controlled diabetes or fasting blood glucose >=10.0mmol/L; 3) patients whose main liver function indexes (ALT and AST) were 2 times higher than the upper limit of normal value;Renal function index (Cr) was 1.5 times higher than the upper limit of normal value.

Design outcomes

Primary

MeasureTime frame
Success rate of hemostasis;—

Secondary

MeasureTime frame
rebleeding rate;—

Countries

China

Contacts

Public ContactLing Xu

Xiamen Gelfeel Bio-Technology Co. ,Ltd

xuling@gelfeel.com+86 18030175970

Outcome results

None listed

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