Efficacy and safety evaluation of Kedrion Fibrin Sealant as an adjuvant for the control of hemostasis in pediatric patients undergoing abdominal or orthopedic surgery. Multicenter, randomized, controlled open label, phase III study

Phase 1

• Conditions: Paediatric patients undergoing abdominal or orthopedic surgery; MedDRA version: 18.0Level: PTClassification code 10067439Term: HaemostasisSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2012-002328-34-IT
• Lead Sponsor: KEDRION S.P.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-19
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Males and females aged <18 years who will experience abdominal or orthopedic surgery; in the case of abdominal surgery, Kedrion Fibrin Glue will be applied at sites with bleeding oozing without foci of punctate bleeding.
2. The subjects and their parents or authorized legal guardians must have received adequate information about the nature of the trial, to agree with the aims of the study and signing the informed consent form, the assent form (if applicable) and the authorization form to the processing of personal data approved by the Ethics Committee (EC).
3. Subjects able to comply with the procedures of the Protocol, including follow-up visits.
Note 1: It will be possible to include patients with either congenital or acquired bleeding disorders, and it is also allowed the inclusion of patients with chronic diseases
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

. Use of other agents adhesives /sealants not provided for the Protocol;
2. Presence of conditions that, in the opinion of the investigator, may interfere with the evaluation of the objective of the study or participation in the study;
3. Previous exposure to products containing bovine aprotinin for less than 12 months (positive to bovine aprotinin antibodies );
4. Known allergies to blood components;
5. Participation in another clinical trial in the month preceding the start of the study (in the last 30 days the subject has taken other investigational drugs);
6. Subjects who are pregnant.

Study & Design

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