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

Completed · Phase 3

Conditions studied: Excessive Bleeding During Surgery

In brief

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).

Key facts

Study ID

NCT03461406

Run by

Instituto Grifols, S.A.

People needed

186

Starts

2019-01-18

Expected to finish

2022-05-20

Last updated by the study team

2023-04-14

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

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:
• Presence of an appropriate (as defined in inclusion criterion 5) parenchymous or soft tissue TBS identified intra-operatively by the investigator (the surgeon).
• 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:
• 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).
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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