Clinical trial NCT04459871: Safety and Efficacy of Topical Recombinant Human Thrombin(rhThrombin) for Surgical Hemostasis
Official title: A Phase 3, Stratified Randomized, Double-blind, Placebo-controlled Study of Topical Recombinant Human Thrombin (rhThrombin) in Surgical Hemostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Hemostasis
Keywords: hepatic resection
rhThrombin,topical
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 criteria: 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.

Primary outcomes:
measure: The rate of complete hemostasis within 6 minutes.
timeFrame: 6 minutes
Secondary outcomes:
measure: Incidence of adverse events(AE)
timeFrame: Up to 28 days
measure: Time to Hemostasis(TTH)
timeFrame: Evaluate the effect of hemostasis every 30sec until hemostasis is completed or 6 minutes of observation is completed
measure: Immunogenicity
timeFrame: At baseline and Day 29
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Sheng Yan, PhD
role: PRINCIPAL_INVESTIGATOR
References: