This study aims to see how good and safe a new body glue (fibrin sealant) product called FS Grifols is in children undergoing surgery. We want to see if it can reduce the time taken to stop bleeding when it is tested against a commercially available body glue called EVICEL®.

Phase 1

• Conditions: Treatment of haemorrage during surgery; Therapeutic area: Body processes [G] - Physical Phenomena [G01]

• Registration Number: EUCTR2016-004489-24-DE
• Lead Sponsor: Instituto Grifols, S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-13
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

Inclusion Criteria:
A subject must meet all the following inclusion criteria to be eligible for participation in this study.
Pre-operative:
1. Is less than 18 years of age.

2. Requires an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure.

3. Subject and/or subject’s legal guardian is willing to give permission for the subject to participate in the clinical trial and provide written informed consent for the subject. In addition, assent must be obtained from pediatric subjects 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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 172
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A subject meeting any of the following exclusion criteria is NOT eligible for participation in the study.
Pre-operative:
1. Subjects admitted for trauma surgery.
2. Subjects unwilling to receive blood products.
3. Subjects with known history of severe (eg, anaphylactic) reaction to blood products.
4. Subjects with known history of intolerance to any of the components of the investigational product (IP).
5. Female subjects who are pregnant, breastfeeding or, if of child-bearing potential (ie, adolescent), unwilling to practice a highly effective method of contraception (eg, oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.
True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.).
6. Subjects previously enrolled in a clinical trial with FS Grifols.
7. Subjects currently participating, or during the study is planned to
participate, in any other investigational device or medicinal product
study.

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. The 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. The 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified