Safety and Efficacy of Topical Recombinant Human Thrombin(rhThrombin) for Surgical Hemostasis
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|ClinicalTrials.gov Identifier: NCT04459871|
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Surgical Hemostasis||Biological: recombinant human Thrombin(CHO cell) Biological: placebo||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||510 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3, Stratified Randomized, Double-blind, Placebo-controlled Study of Topical Recombinant Human Thrombin (rhThrombin) in Surgical Hemostasis|
|Actual Study Start Date :||November 8, 2019|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||August 1, 2021|
Experimental: The experimental group
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)
2 rhThrombin, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).
Other Name: rhThrombin
Placebo Comparator: The control group
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).
placebo, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).
- The rate of complete hemostasis within 6 minutes. [ Time Frame: 6 minutes ]Those who did not stop bleeding within 6 minutes were defined as treatment failure.
- Incidence of adverse events(AE) [ Time Frame: Up to 28 days ]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.
- Time to Hemostasis(TTH) [ Time Frame: Evaluate the effect of hemostasis every 30sec until hemostasis is completed or 6 minutes of observation is completed ]TTH will be assessed for up to 6 minutes
- Immunogenicity [ Time Frame: At baseline and Day 29 ]Positive rate of anti-recombinant human thrombin neutralizing antibody.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459871
|Contact: Sheng Yan, PhDfirstname.lastname@example.org|
|The First Affiliated Hospital, Zhejiang University School of Medicine||Recruiting|
|Hangzhou, Zhejiang, China|
|Contact: Sheng Yan, PhD 86-13957161680 email@example.com|
|Principal Investigator:||Sheng Yan, PhD||The First Affiliated Hospital, Zhejiang University School of Medicine|