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

NCT ID: NCT03461406

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-18
• Study Completion Date: 2022-05-20

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.

Conditions

Excessive Bleeding During Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fibrin Sealant Grifols

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.

Group Type: EXPERIMENTAL

Fibrin Sealant Grifols

Intervention Type: BIOLOGICAL

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

EVICEL

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.

Group Type: ACTIVE_COMPARATOR

EVICEL

Intervention Type: BIOLOGICAL

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

Interventions

Fibrin Sealant Grifols

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

Intervention Type: BIOLOGICAL

EVICEL

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

Intervention Type: BIOLOGICAL

Other Intervention Names

FS Grifols

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:

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.

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Grifols, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States

University of Michigan

Michigan Center, Michigan, United States

The Urological Institute of Northeastern New York

Albany, New York, United States

Columbia Medical Center

New York, New York, United States

St. Christophers Hospital

Philadelphia, Pennsylvania, United States

MUSC Health-Children's Hospital

Charleston, South Carolina, United States

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

Children's Medical Center Dallas

Dallas, Texas, United States

El Paso Childrens Hospital

El Paso, Texas, United States

Memorial Hermann Memorial City

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Carilion Children's Pediatric Surgery

Roanoke, Virginia, United States

MHAT City clinic - Sveti Georgi

Montana, , Bulgaria

UMHAT Dr. Georgi Stranski

Pleven, , Bulgaria

UMHAT Sveti Georgi

Plovdiv, , Bulgaria

UMHAT Kanev

Rousse, , Bulgaria

UMHATEM N.I.Pirogov

Sofia, , Bulgaria

UMHAT Prof. Dr. Stoyan Kirkovich

Stara Zagora, , Bulgaria

British Columbia's Children's Hospital

Vancouver, , Canada

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, , France

Hôpital Armand Trousseau - APHP

Paris, , France

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Semmelweis University, 2nd Dpt of Paediatrics

Budapest, , Hungary

Heim Pál Pediatric Hospital

Budapest, , Hungary

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

Debrecen, , Hungary

Petz Aladár County Teaching Hospital, Department of Pediatric Surgery

Győr, , Hungary

University of Pécs Clinical Centre, Pediatric Clinic

Pécs, , Hungary

Spitalul Clinic de Urgenta pentru Copii "Grigore Alexandrescu"

Bucharest, , Romania

Spitalul Clinic de Urgenta pentru Copii "Maria Sklodowska Curie"

Bucharest, , Romania

Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca

Cluj-Napoca, , Romania

Spitalul Clinic de Urgenta pentru Copii "Sfanta Maria"

Iași, , Romania

Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu"

Timișoara, , Romania

University Children' s Hospital

Belgrade, , Serbia

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

Belgrade, , Serbia

Clinical Centre Nis, Clinic for Pediatric Surgery and Orthopedics

Niš, , Serbia

Insititute for Health Protection of Children and Youth

Novi Sad, , Serbia

Karolinska Universitetssjukhuset

Huddinge, Stockholm County, Sweden

Birmingham Children's Hospital NHS Foundation Trust

Birmingham, , United Kingdom

Clesea & Westmisnter Hospital

London, , United Kingdom

Southampton Children's Hospital

Southampton, , United Kingdom

Countries

United States; Bulgaria; Canada; France; Germany; Hungary; Romania; Serbia; Sweden; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-004489-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IG1405

Identifier Type: -

Identifier Source: org_study_id