Clinical trial
A Phase 3, Stratified Randomized, Double-blind, Placebo-controlled Study of Topical Recombinant Human Thrombin (rhThrombin) in Surgical Hemostasis
Name
ZGrhT002
Description
A multicenter, stratified randomized, double-blind, placebo-controlled, phase 3 clinical trial.
Trial arms
Trial start
2019-11-11
Estimated PCD
2021-10-20
Trial end
2021-10-20
Status
Completed
Phase
Early phase I
Treatment
recombinant human Thrombin(CHO cell)
2 rhThrombin, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).
Arms:
The experimental group
Other names:
rhThrombin
placebo
placebo, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).
Arms:
The control group
Size
348
Primary endpoint
The rate of complete hemostasis within 6 minutes.
6 minutes
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 348, 'type': 'ACTUAL'}}
Updated at
2022-11-29
1 organization
2 products
1 indication
Organization
Suzhou Zelgen BiopharmaceuticalsProduct
Recombinant Human ThrombinIndication
Surgical HemostasisProduct
placebo