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

PHASE3CompletedINTERVENTIONAL
Enrollment

186

Participants

Timeline

Start Date

January 18, 2019

Primary Completion Date

April 15, 2022

Study Completion Date

May 20, 2022

Conditions
Excessive Bleeding During Surgery
Interventions
BIOLOGICAL

Fibrin Sealant Grifols

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

BIOLOGICAL

EVICEL

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

Trial Locations (40)

1094

Semmelweis University, 2nd Dpt of Paediatrics, Budapest

1606

UMHATEM N.I.Pirogov, Sofia

3400

MHAT City clinic - Sveti Georgi, Montana

4001

UMHAT Sveti Georgi, Plovdiv

4480

British Columbia's Children's Hospital, Vancouver

5800

UMHAT Dr. Georgi Stranski, Pleven

6000

UMHAT Prof. Dr. Stoyan Kirkovich, Stara Zagora

6200

Hôpitaux Pédiatriques de Nice CHU-Lenval, Nice

7000

UMHAT Kanev, Rousse

10032

Columbia Medical Center, New York

11000

University Children' s Hospital, Belgrade

11070

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

12208

The Urological Institute of Northeastern New York, Albany

14186

Karolinska Universitetssjukhuset, Huddinge

18000

Clinical Centre Nis, Clinic for Pediatric Surgery and Orthopedics, Niš

19134

St. Christophers Hospital, Philadelphia

21000

Insititute for Health Protection of Children and Youth, Novi Sad

24013

Carilion Children's Pediatric Surgery, Roanoke

29425

MUSC Health-Children's Hospital, Charleston

38163

Le Bonheur Children's Hospital, Memphis

48109

University of Michigan, Michigan Center

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

60611

Lurie Childrens Hospital of Chicago, Chicago

75012

Hôpital Armand Trousseau - APHP, Paris

75235

Children's Medical Center Dallas, Dallas

77024

Memorial Hermann Memorial City, Houston

79905

El Paso Childrens Hospital, El Paso

84112

University of Utah, Salt Lake City

300011

"Spitalul Clinic de Urgenta pentru Copii Louis Turcanu", Timișoara

400370

Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca, Cluj-Napoca

700309

"Spitalul Clinic de Urgenta pentru Copii Sfanta Maria", Iași

H-1089

Heim Pál Pediatric Hospital, Budapest

H-4032

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

H-9023

Petz Aladár County Teaching Hospital, Department of Pediatric Surgery, Győr

H-7623

University of Pécs Clinical Centre, Pediatric Clinic, Pécs

010623

"Spitalul Clinic de Urgenta pentru Copii Grigore Alexandrescu", Bucharest

041434

"Spitalul Clinic de Urgenta pentru Copii Maria Sklodowska Curie", Bucharest

B46NH

Birmingham Children's Hospital NHS Foundation Trust, Birmingham

SW109NH

Clesea & Westmisnter Hospital, London

SO166YD

Southampton Children's Hospital, Southampton

All Listed Sponsors
lead

Instituto Grifols, S.A.

INDUSTRY

NCT03461406 - A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants | Biotech Hunter | Biotech Hunter