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

NCT04459871 | Completed Phase 3

• 1 other identifier: ZGrhT002
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgical Hemostasis

Keywords

hepatic resection; rhThrombin,topical

Outcome Measures

Primary Outcomes (1)

• The rate of complete hemostasis within 6 minutes.

  Those who did not stop bleeding within 6 minutes were defined as treatment failure.

  6 minutes

Secondary Outcomes (3)

• Incidence of adverse events(AE)

  Up to 28 days

• Time to Hemostasis(TTH)

  Evaluate the effect of hemostasis every 30sec until hemostasis is completed or 6 minutes of observation is completed

• Immunogenicity

  At baseline and Day 29

Study Arms (2)

The experimental group

EXPERIMENTAL

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).

Biological: recombinant human Thrombin(CHO cell)

The control group

PLACEBO COMPARATOR

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).

Biological: placebo

Interventions

recombinant human Thrombin(CHO cell) BIOLOGICAL

2 rhThrombin, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).

Also known as: rhThrombin

The experimental group

placebo BIOLOGICAL

placebo, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).

The control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

recombinant human thrombin

Study Officials

• Sheng Yan, PhD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: November 11, 2019
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CN (1)