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Safety and Efficacy of Topical Recombinant Human Thrombin(rhThrombin) for Surgical Hemostasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Efficacy of Topical Recombinant Human Thrombin(rhThrombin) for Surgical Hemostasis

A Phase 3, Stratified Randomized, Double-blind, Placebo-controlled Study of Topical Recombinant Human Thrombin (rhThrombin) in Surgical Hemostasis

NCT04459871•Suzhou Zelgen Biopharmaceuticals Co.,Ltd

View on ClinicalTrials.gov

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 study drug (rhThrombin or placebo) in combination with an absorbable gelatin sponge at appropriate bleeding evaluation site(s). 510 patients will participate in the study. In this study, stratified random enrollment was conducted according to the condition(experimental group or control group) of the subjects.Stratification factors were centered, gender (male/female) and age (18 ≤ age \<60/60 ≤ age ≤70).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

November 11, 2019

Primary Completion Date

October 20, 2021

Completion Date

October 20, 2021

Last Updated

November 29, 2022

Enrollment

348

ACTUAL participants

Conditions

Surgical Hemostasis

Interventions

recombinant human Thrombin(CHO cell)

BIOLOGICAL

placebo

BIOLOGICAL

Comparative Study Between the Effect of Dexmedetomidine ,Midazolam or Bupivacaine Packing During FESS on Surgical Field Visualization

NCT07013955

Surgical Hemostasis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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