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A multicenter, stratified randomized, double-blind, placebo-controlled, phase 3 clinical trial.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of complete hemostasis within 6 minutes. | Those who did not stop bleeding within 6 minutes were defined as treatment failure. | 6 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events(AE) | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. | Up to 28 days |
| Time to Hemostasis(TTH) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheng Yan, PhD | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| C513462 | recombinant human thrombin |
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| placebo | Biological | placebo, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid). |
|
TTH will be assessed for up to 6 minutes
| Evaluate the effect of hemostasis every 30sec until hemostasis is completed or 6 minutes of observation is completed |
| Immunogenicity | Positive rate of anti-recombinant human thrombin neutralizing antibody. | At baseline and Day 29 |