Clinical trial NCT03461406: A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Excessive Bleeding During Surgery
Lead sponsor: Grifols Therapeutics LLC
Sponsor class: INDUSTRY
First posted: 2018-03-12
Enrollment: 186
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants 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).

Detailed description: 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 participants 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 participants 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 participant eligibility, a Baseline Visit, the Surgical Procedure (Day 1), and Post-operative assessments at Days 1, 4, and 30. The total duration of a participant'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.

Eligibility criteria: Inclusion Criteria:

Pre-operative:

1. Less than 18 years of age.
2. Requires an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure.
3. Participant and/or participant's legal guardian is willing to give permission for the participant to participate in the clinical trial and provide written informed consent for the participant. In addition, assent must be obtained from pediatric participants 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.

Exclusion Criteria:

Pre-operative:

1. Admitted for trauma surgery.
2. Unwilling to receive blood products.
3. Known history of severe (eg, anaphylactic) reaction to blood products.
4. Known history of intolerance to any of the components of the investigational product (IP).
5. Female participants who are pregnant, breastfeeding or, if of child-bearing potential (ie, adolescent), unwilling to practice a highly effective method of contraception.
6. Previously enrolled in a clinical trial with FS Grifols.
7. 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. 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. 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.

Primary outcomes:
measure: Percentage of Participants Achieving Hemostasis Within 4 Minutes After Treatment Start (T4)
timeFrame: From start of treatment until 4 minutes after treatment start (Day 1)
Secondary outcomes:
measure: Cumulative Percentage of Participants Achieving Hemostasis at the TBS by the 7 Minutes After Treatment Start (T7)
timeFrame: From start of treatment to 7 minutes after start of treatment (Day 1)
measure: Cumulative Percentage of Participants Achieving Hemostasis at the Target Bleeding Site by 10 Minutes After Treatment Start (T10)
timeFrame: From start of treatment to 10 minutes after start of treatment (Day 1)
measure: Percentage of Participants With Treatment Failures
timeFrame: From start of treatment to 10 minutes after start of treatment and until the time of completion of surgical closure (Day 1)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lurie Childrens Hospital of Chicago
state: Illinois
city: Michigan Center
country: United States
facility: University of Michigan
state: Michigan
city: Albany
country: United States
facility: The Urological Institute of Northeastern New York
state: New York
city: New York
country: United States
facility: Columbia Medical Center
state: New York
city: Philadelphia
country: United States
facility: St. Christophers Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC Health-Children's Hospital
state: South Carolina
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: El Paso
country: United States
facility: El Paso Childrens Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Memorial City
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Roanoke
country: United States
facility: Carilion Children's Pediatric Surgery
state: Virginia
city: Montana
country: Bulgaria
facility: MHAT City clinic - Sveti Georgi
city: Pleven
country: Bulgaria
facility: UMHAT Dr. Georgi Stranski
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi
city: Ruse
country: Bulgaria
facility: UMHAT Kanev
city: Sofia
country: Bulgaria
facility: UMHATEM N.I.Pirogov
city: Stara Zagora
country: Bulgaria
facility: UMHAT Prof. Dr. Stoyan Kirkovich
city: Vancouver
country: Canada
facility: British Columbia's Children's Hospital
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU-Lenval
city: Paris
country: France
facility: Hôpital Armand Trousseau - APHP
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Budapest
country: Hungary
facility: Semmelweis University, 2nd Dpt of Paediatrics
city: Budapest
country: Hungary
facility: Heim Pál Pediatric Hospital
city: Debrecen
country: Hungary
facility: University of Debrecen Clinical Center, Pediatric Clinic No. I.
city: Győr
country: Hungary
facility: Petz Aladár County Teaching Hospital, Department of Pediatric Surgery
city: Pécs
country: Hungary
facility: University of Pécs Clinical Centre, Pediatric Clinic
city: Bucarest
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii "Maria Sklodowska Curie"
city: Bucharest
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii "Grigore Alexandrescu"
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca
city: Iasi
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii "Sfanta Maria"
city: Timişoara
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu"
city: Belgrade
country: Serbia
facility: University Children' s Hospital
city: Belgrade
country: Serbia
facility: Mother and Child Healthcare Institute of Serbia "Dr Vukan Cupic"
city: Nis
country: Serbia
facility: Clinical Centre Nis, Clinic for Pediatric Surgery and Orthopedics
city: Novi Sad
country: Serbia
facility: Insititute for Health Protection of Children and Youth
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset
state: Stockholm
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Clesea & Westmisnter Hospital
city: Southampton
country: United Kingdom
facility: Southampton Children's Hospital
Study officials:
References: