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

Zelgen Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Surgical Hemostasis

Treatments: Biological: recombinant human Thrombin(CHO cell); Biological: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04459871

ZGrhT002

Details and patient eligibility

About

A multicenter, stratified randomized, double-blind, placebo-controlled, phase 3 clinical trial.

Full 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).

Enrollment: 348 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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348 participants in 2 patient groups, including a placebo group

The experimental group

Experimental group

Description:

The topical recombinant human thrombin(rhThrombin) was prepared into 1000IU/mL solution with 10ml normal saline and used in combination with absorbable gelatin spongeat at appropriate bleeding evaluation site(s).

Treatment:

Biological: recombinant human Thrombin(CHO cell)

The control group

Placebo Comparator group

Description:

The placebo was prepared into a solution with 10mL normal saline and used in combination with absorbable gelatin sponge at appropriate bleeding evaluation site(s).

Treatment:

Biological: placebo