Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Subjects
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|ClinicalTrials.gov Identifier: NCT03461406|
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : June 2, 2020
This is a prospective, randomized, active-controlled, single-blind, parallel group clinical trial to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during surgery in pediatric subjects.
Pediatric subjects (<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 the clinical trial.
The study treatments will be applied on the cut parenchymous surface of a solid organ (ie, liver) and in soft tissue (ie, fat, muscle, or connective tissue).
|Condition or disease||Intervention/treatment||Phase|
|Excessive Bleeding During Surgery||Biological: Fibrin Sealant Grifols Biological: EVICEL||Phase 3|
This is a prospective, randomized, active-controlled, single-blind, parallel group clinical trial to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during surgery. Approximately 172 pediatric subjects will be enrolled and will be randomly allocated in a 1:1 ratio into 1 of 2 treatment groups: FS Grifols or EVICEL. Enrollment will be monitored by surgery type to ensure at least 50% of the surgical procedures are hepatic.
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 a 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 (ie, 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.
This study includes a Screening Visit to determine subject eligibility, a Baseline Visit, the Surgical Procedure (Day 1), and Post-operative assessments at Days 1, 4, and 30. The total duration of a subject's participation in this study is expected to be no longer than 2 months from the Screening Visit to the Post-operative Day 30 Visit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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 Paediatric Subjects|
|Actual Study Start Date :||December 5, 2018|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Fibrin Sealant Grifols
human fibrinogen (component 1: 80 mg/mL solution) and human thrombin (component 2: 500 IU/mL solution)
Biological: Fibrin Sealant Grifols
human fibrinogen (component 1: 80 mg/mL solution) and human thrombin (component 2: 500 IU/mL solution) solutions filled in syringes and assembled on a syringe holder
Other Name: FS Grifols
Active Comparator: EVICEL
human fibrinogen (55-85 mg/mL) and human thrombin (800-1200 IU/mL)
1 vial of Biological Active Component 2, a frozen, sterile solution consisting of a concentrate of human fibrinogen (55-85 mg/mL) and 1 vial of thrombin (800-1200 IU/mL)
- Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start (T4) [ Time Frame: From start of treatment until 4 minutes after treatment start ]Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding or reapplication of study treatment after T4 and until the completion of surgical closure.
- Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 7 Minutes After Treatment Start (T7). [ Time Frame: From start of treatment to 7 minutes after start of treatment. ]
- Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 10 Minutes After Treatment Start (T10). [ Time Frame: From start of treatment to 10 minutes after start of treatment. ]
- Prevalence of Treatment Failures [ Time Frame: From start of treatment up to 10 minutes after start of treatment and until the time of completion of surgical closure. ]
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): NCT03461406
|Contact: Jordi Navarro Puerto||+34 93 571 2200||Jordi.Navarro@grifols.com|