A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants

NCT03461406 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: IG14052016-004489-24
• Study Type: interventional
• Target: 186
• Locations: 9 countries
• Sites: 36

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).

Conditions

Excessive Bleeding During Surgery

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Hemostasis Within 4 Minutes After Treatment Start (T4)

  Hemostasis is defined as Grade 0 bleeding per 5-point validated bleeding severity scale (0=no bleeding and 4=Unidentified or inaccessible spurting or gush) at the target bleeding site (TBS) according to the investigator's (surgeon's) judgment, so that the surgical closure of the exposed field could begin.

  From start of treatment until 4 minutes after treatment start (Day 1)

Secondary Outcomes (3)

• Cumulative Percentage of Participants Achieving Hemostasis at the TBS by the 7 Minutes After Treatment Start (T7)

  From start of treatment to 7 minutes after start of treatment (Day 1)

• Cumulative Percentage of Participants Achieving Hemostasis at the Target Bleeding Site by 10 Minutes After Treatment Start (T10)

  From start of treatment to 10 minutes after start of treatment (Day 1)

• Percentage of Participants With Treatment Failures

  From start of treatment to 10 minutes after start of treatment and until the time of completion of surgical closure (Day 1)

Study Arms (2)

Fibrin Sealant Grifols

EXPERIMENTAL

Participants topically applied FS Grifols, which consisted of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder.

Biological: Fibrin Sealant Grifols

EVICEL

ACTIVE COMPARATOR

Participants topically applied EVICEL, which consisted of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically.

Biological: EVICEL

Interventions

Fibrin Sealant Grifols BIOLOGICAL

The FE Grifols solution was applied topically via drip or spray application.

Also known as: FS Grifols

Fibrin Sealant Grifols

EVICEL BIOLOGICAL

The EVICEL solution was applied topically via drip or spray application.

EVICEL

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pre-operative:
• Less than 18 years of age.
• Requires an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure.
• 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:
• 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.

You may not qualify if:

• Pre-operative:
• Admitted for trauma surgery.
• Unwilling to receive blood products.
• Known history of severe (eg, anaphylactic) reaction to blood products.
• Known history of intolerance to any of the components of the investigational product (IP).
• Female participants who are pregnant, breastfeeding or, if of child-bearing potential (ie, adolescent), unwilling to practice a highly effective method of contraception.
• Previously enrolled in a clinical trial with FS Grifols.
• 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:
• 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.
• TBS is in an actively infected surgical field.
• Occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.
• Application of any topical hemostatic agent on the resection surface of parenchyma or soft tissue prior to application of the IP.

Sponsors & Collaborators

• Instituto Grifols, S.A.: lead

Study Sites (40)

Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

University of Michigan

Michigan Center, Michigan, 48109, United States

Location

The Urological Institute of Northeastern New York

Albany, New York, 12208, United States

Location

Columbia Medical Center

New York, New York, 10032, United States

Location

St. Christophers Hospital

Philadelphia, Pennsylvania, 19134, United States

Location

MUSC Health-Children's Hospital

Charleston, South Carolina, 29425, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38163, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

El Paso Childrens Hospital

El Paso, Texas, 79905, United States

Location

Memorial Hermann Memorial City

Houston, Texas, 77024, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Carilion Children's Pediatric Surgery

Roanoke, Virginia, 24013, United States

Location

MHAT City clinic - Sveti Georgi

Montana, 3400, Bulgaria

Location

UMHAT Dr. Georgi Stranski

Pleven, 5800, Bulgaria

Location

UMHAT Sveti Georgi

Plovdiv, 4001, Bulgaria

Location

UMHAT Kanev

Rousse, 7000, Bulgaria

Location

UMHATEM N.I.Pirogov

Sofia, 1606, Bulgaria

Location

UMHAT Prof. Dr. Stoyan Kirkovich

Stara Zagora, 6000, Bulgaria

Location

British Columbia's Children's Hospital

Vancouver, 4480, Canada

Location

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, 6200, France

Location

Hôpital Armand Trousseau - APHP

Paris, 75012, France

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Semmelweis University, 2nd Dpt of Paediatrics

Budapest, 1094, Hungary

Location

Heim Pál Pediatric Hospital

Budapest, H-1089, Hungary

Location

University of Debrecen Clinical Center, Pediatric Clinic No. I.

Debrecen, H-4032, Hungary

Location

Petz Aladár County Teaching Hospital, Department of Pediatric Surgery

Győr, H-9023, Hungary

Location

University of Pécs Clinical Centre, Pediatric Clinic

Pécs, H-7623, Hungary

Location

Spitalul Clinic de Urgenta pentru Copii "Grigore Alexandrescu"

Bucharest, 010623, Romania

Location

Spitalul Clinic de Urgenta pentru Copii "Maria Sklodowska Curie"

Bucharest, 041434, Romania

Location

Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca

Cluj-Napoca, 400370, Romania

Location

Spitalul Clinic de Urgenta pentru Copii "Sfanta Maria"

Iași, 700309, Romania

Location

Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu"

Timișoara, 300011, Romania

Location

University Children' s Hospital

Belgrade, 11000, Serbia

Location

Mother and Child Healthcare Institute of Serbia "Dr Vukan Cupic"

Belgrade, 11070, Serbia

Location

Clinical Centre Nis, Clinic for Pediatric Surgery and Orthopedics

Niš, 18000, Serbia

Location

Insititute for Health Protection of Children and Youth

Novi Sad, 21000, Serbia

Location

Karolinska Universitetssjukhuset

Huddinge, Stockholm County, 14186, Sweden

Location

Birmingham Children's Hospital NHS Foundation Trust

Birmingham, B46NH, United Kingdom

Location

Clesea & Westmisnter Hospital

London, SW109NH, United Kingdom

Location

Southampton Children's Hospital

Southampton, SO166YD, United Kingdom

Location

Results Point of Contact

• Title: Sandra Camprubi Gimenez
• Organization: Instituto Grifols, S.A.

sandra.camprubi@grifols.com

+34670923160

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 12, 2018
• Study Start: January 18, 2019
• Primary Completion: April 15, 2022
• Study Completion: May 20, 2022
• Last Updated: April 14, 2023
• Results First Posted: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); SE (1); GB (3); RO (5); HU (5); BU (6); US (12); DE (1); CA (1)