Treatment of haemorrage during surgery
Conditions
Interventions
Trade Name: VeraSeal
Product Name: FS Grifols
Pharmaceutical Form: Solution for sealant
INN or Proposed INN: Human Fibrinogen
CAS Number: 9001-32-5
Other descriptive name: HUMAN FIBRINOGEN
Concentrat
Sponsors
Instituto Grifols, S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: A subject must meet all the following inclusion criteria to be eligible for participation in this study. Pre-operative: 1. Is less than 18 years of age. 2. Requires an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure. 3. Subject and/or subject’s legal guardian is willing to give permission for the subject to participate in the clinical trial and provide written informed consent for the subject. In addition, assent must be obtained from pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the clinical trial. Intra-operative: 4. Presence of an appropriate (as defined in inclusion criterion 5) parenchymous or soft tissue TBS identified intra-operatively by the investigator (the surgeon). 5. TBS has Grade 1 (mild) or Grade 2 (moderate) bleeding intensity according to the investigator’s (the surgeon’s) judgment. The intensity of the bleeding at the TBS will be rated by the investigator using the 5-point validated bleeding severity scale. Are the trial subjects under 18? yes Number of subjects for this age range: 172 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject meeting any of the following exclusion criteria is NOT eligible for participation in the study. Pre-operative: 1. Subjects admitted for trauma surgery. 2. Subjects unwilling to receive blood products. 3. Subjects with known history of severe (eg, anaphylactic) reaction to blood products. 4. Subjects with known history of intolerance to any of the components of the investigational product (IP). 5. Female subjects who are pregnant, breastfeeding or, if of child-bearing potential (ie, adolescent), unwilling to practice a highly effective method of contraception (eg, oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study. True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.). 6. Subjects previously enrolled in a clinical trial with FS Grifols. 7. Subjects currently participating, or during the study is planned to participate, in any other investigational device or medicinal product study without prior and explicit approval from the sponsor. Intra-operative: 8. An appropriate parenchymous or soft tissue TBS (as defined in exclusion criteria 9 and 10) cannot be identified intra-operatively by the investigator (the surgeon). 9. The TBS has Grade 3 (severe) bleeding according to the investigator’s (the surgeon’s) judgment that cannot be controlled with conventional surgical techniques to Grade 1 or Grade 2 bleeding. The intensity of the bleeding at the TBS will be rated by the investigator using the 5-point validated bleeding severity scale. 10. The TBS is in an actively infected surgical field. 11. Occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure. 12. Application of any topical hemostatic agent on the resection surface of parenchyma or soft tissue prior to application of the IP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary efficacy endpoint in this clinical trial is the proportion of subjects achieving hemostasis at the TBS by T4, with no occurrence of rebleeding until the completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure).;Main Objective: The objectives of this study are to evaluate the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) as an adjunct to achieve hemostasis during surgery in pediatric subjects. Primary Efficacy Objective • To evaluate if FS Grifols is non-inferior to EVICEL® in terms of the proportion of subjects achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment application (TStart) with no occurrence of rebleeding until the completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure). Safety Objective To evaluate the safety and tolerability of FS Grifols in pediatric subjects undergoing surgery;Secondary Objective: Secondary Efficacy Objectives • To determine the cumulative proportion of subjects achieving hemostasis at the TBS by the defined observation time points of 7 minutes (T7) and 10 minutes (T10) from TStart • To determine prevalence of treatment failures Exploratory Efficacy Objectives • To determine the proportion of subjects achieving at least 1 point decrease in bleeding intensity according to the 5-point validated bleeding severity scale by the defined observation time points of T4, T7, and T10 • To determine the mean change from baseline in bleeding intensity according to the 5 point validated bleeding severity scale at the defined observation time points of T4, T7, and T10 ;Timepoint(s) of evaluation of this end point: T4: 4 minutes after start of treatment application | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Cumulative proportion of subjects achieving hemostasis at the TBS by the defined observation time points of T7 and T10 • Prevalence of treatment failures ;Timepoint(s) of evaluation of this end point: T7 and T10: 7 and 10 minutes after start of treatment application | — |
Countries
Bulgaria, Canada, France, Germany, Hungary, Netherlands, Romania, Serbia, Sweden, United Kingdom, United States
Contacts
Public ContactDepartment of Clinical Trials
Instituto Grifols, S.A.
Outcome results
None listed