A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to evaluate the safety and efficacy of Fibrin Sealant Grifols (FS-Grifols) as an adjunct to haemostasis during surgery in Pediatric subjects.
Study ID: STU 062018-049
This is a prospective, randomized, active-controlled, single-blind, parallel group clinical trial to evaluate the efficacy and safety of FS Grifols as an adjunct to hemostasis during surgery in pediatric subjects. Subjects will be randomly allocated in a 1:1 ratio into 1 of 2 treatment groups: FS Grifols or eViCeL. The first 24 subjects to be enrolled in the study will be adolescents (age range 12 to 17 years). (note:enrolled implies that the subject was actually randomized to and treated with either the FS Grifols or eViCeL). enrollment will be monitored by surgery type to ensure at least 50% of the surgical procedures are hepatic. Randomization will be stratified by the type of surgery (i.e. parenchymous versus soft tissue surgery) and age groups (i.e. 12-17 years, 2-11 years, 28 days-23 months, and 0-27 days). Pediatric subjects ([Less Than]18 years of age) requiring an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure, wherein a target bleeding site (TBS) is identified, and a topical hemostatic agent is indicated, will be eligible to participate in this clinical trial. The study treatments will be applied on the cut parenchymous surface of a solid organ (i.e., liver) and in soft tissue (i.e., fat, muscle, or connective tissue). a specific bleeding site will be defined as the TBS when it is determined by the investigator (the surgeon) that control of bleeding by conventional surgical techniques (including suture, ligature, and cautery) is ineffective or impractical and requires an adjunct treatment to achieve hemostasis. When the TBS is identified, the investigator will record the precise anatomical location of the TBS, rate the intensity of the bleeding at the TBS (Grade 1-4 according to the 5-point validated bleeding severity scale), and record the size of the approximate bleeding surface, (small, medium, and large). For soft tissue surgery only, the investigator will also record the type of soft tissue (i.e., fat, muscle, or connective tissue). in this clinical trial, only subjects with a TBS with bleeding of Grade 1 (mild) or Grade 2 (moderate) intensity will be enrolled. Key Study Variables: Primary efficacy Variables: The primary efficacy variable is the proportion of subjects achieving hemostasis (binary decision: hemostatic response, Grade 0 [?] Yes/Grade [GreaterThanorequalTo]1 [?] no) at the TBS by T4 without occurrence of rebleeding or reapplication of study treatment after T4 and until the time of completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure), and without Grade 3 or 4 bleeding or use of alternative hemostatic treatment after TStart and until TClosure. Secondary efficacy Variables: -The cumulative proportion of subjects achieving hemostasis at the TBS by the time points of T7 and T10 defined as an absence/cessation of bleeding (Grade 0) at the TBS by that time point without occurrence of rebleeding, Grade 3 or 4 bleeding, use of alternative hemostatic treatment, and reapplication of study treatment after T4 and until TClosure. -Prevalence of treatment failures including: -Persistent bleeding at the TBS beyond T4 - Grade 3 or 4 breakthrough bleeding from the TBS that jeopardizes subject safety according to the investigator's judgment at any moment during the 10-minute observational period and until TClosure - use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure or use of study treatment at the TBS beyond T4 and until TClosure - Rebleeding (Grade [GreaterThanorequalTo]1) at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure exploratory efficacy Variables:-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
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[Single Quote]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.(Please note : Assent will 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[Single Quote]s (the surgeon[Single Quote]s) judgment. The intensity of the bleeding at the TBS will be rated by the investigator using the 5-point validated bleeding severity scale.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- DEV MAHENDRA DESAI
GRIFOLS WORLDWIDE OPERATIONS LTD
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. Study objectives: The primary efficacy objective is to evaluate if FS Grifols is non-inferior to eViCeL[RegisteredTM] 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). The secondary efficacy objectives are 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., and to determine prevalence of treatment failures. The exploratory efficacy objectives are 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 of T4, T7,and T10; and to determine the mean change from baseline in bleeding intensity according to the 5-point validated bleeding severity scale by the defined observation times of T4, T7,and T10. This study will evaluate the safety and tolerability of FS Grifols in pediatric subjects undergoing surgery. Study aim: The aim of this study is to demonstrate that FS Grifols application is not inferior in providing benefit in terms of hemostasis, when compared to the application of a licensed widely used adjunct to hemostasis agent, specifically the commercially available fibrin sealant (FS) solution eViCeL[RegisteredTM]. Hypotheses and rationale: The investigational product FS Grifols is a 2-component frozen sterile FS solution filled in syringes assembled on a syringe holder. FS Grifols is composed of frozen solutions of human fibrinogen and human thrombin with calcium chloride. Fibrin sealants have been used in various diseases and clinical situations. Fibrin sealant products have been also used in a wide range of surgical specialties.The newly developed FS Grifols is intended for local application and a local effect. after adequate nonclinical studies, a clinical development plan was designed to assess the safety and efficacy of FS Grifols in the surgical setting as adjunct to local hemostasis. Safety and efficacy of FS Grifols was assessed during the clinical development of FS Grifols. The clinical development program consisted of 3 pivotal phase 3 clinical trials: iG1101 (vascular surgery), iG1102 (parenchymous surgery), and iG1103 (soft tissue surgery). all 3 trials were phase 3, prospective, single-blind, randomized studies to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis. in the 3 studies, approximately 500 subjects were treated with FS Grifols and the results from all 3 trials demonstrated that FS Grifols was effective, safe, and well tolerated as a local hemostatic agent in various surgery types.