Status:
COMPLETED
Safety and Efficacy of Topical Recombinant Human Thrombin(rhThrombin) for Surgical Hemostasis
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Conditions:
Surgical Hemostasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
A multicenter, stratified randomized, double-blind, placebo-controlled, phase 3 clinical trial.
Detailed Description
After establishing eligibility, subjects will be randomized in a 2:1 ratio to receive rhThrombin (1000 U/mL) or placebo. During a surgical procedure, study participants will be treated with blinded st...
Eligibility Criteria
Inclusion
- 18 to 70 years old (including 18 and 70 years old), male or female;
- Patients with wedge-shaped liver resection or anatomical liver resection(1-5 consecutive liver segments);
- After the operation was controlled by standard surgical hemostasis, there were still patients with mild/moderate bleeding lesions (bleeding, non-arterial bleeding);
- Electrolytes (K, Na, CL, Ca, P, Mg) and ECG are normal or abnormal, Investigators believe that patients who do not affect surgery
- No other therapeutic surgery within 4 weeks before enrollment;
- Patients who have not used blood products within 24 hours before surgery;
- In compliance with the requirements of the ethics committee, patients voluntarily signed informed consent and were able to conduct visits as required by the protocol.
Exclusion
- Known diseases of the blood system, including patients with coagulopathy or bleeding tendency;
- Patients with unstable vital signs for more than 24 hours;
- A history of severe heart, brain, and vascular disease within 6 months, including patients with a history of TIA, non-disabling cerebral infarction, myocardial infarction, unstable angina, or intracranial hemorrhage;
- Active bleeding or abnormal coagulation function (PT\>16s, APTT\>43s, INR≥2) or receiving thrombolysis, anticoagulation or antiplatelet therapy;
- Have used drugs that affect the function of the coagulation system within 1 week before surgery (including but not limited to: aspirin, clopidogrel, ticlopidine, fensulfamide, desmopressin, aminotoluic acid, dipyridamole, ginkgo Leaf preparations, heparin, warfarin, citrate, hemagglutinin, Vk, anti-fibrotic solvents, hemostatic, Vc, etc.);
- Women during pregnancy and lactation;
- Participants who participated in clinical trials of other drugs within 4 weeks before enrollment.
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2021
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT04459871
Start Date
November 11 2019
End Date
October 20 2021
Last Update
November 29 2022
Active Locations (1)
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1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China