Effect of prophylactic fibrinogen concentrate in surgery of abnormal lateral curvature of the spine: A randomized pilot study (EFISS trial)

Phase 1

• Conditions: Scoliosis; MedDRA version: 20.0Level: PTClassification code 10039727Term: Scoliosis surgerySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2021-005493-25-CZ
• Lead Sponsor: Fakultní nemocnice Brno

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-08
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Age < 18 years of age at the time of enrolment
2. Elective scoliosis surgery
3. Signed the relevant informed consent form
4. Sexually active participants (= 15 years old) must agree to the use of following methods of contraception for the duration of this clinical trial:
a) Women - proper use of a highly reliable method of contraception, i.e. combined hormonal contraception (oral, vaginal or transdermal form), gestagen hormonal contraceptives associated with ovulation inhibition (oral or injectable form) or sexual abstinence.
b) Men - sexual abstinence or the use of an adequate contraceptive method (i.e. condom) in case of sexual intercourse.
Are the trial subjects under 18? yes
Number of subjects for this age range: 32
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

1. Diagnosed congenital or acquired coagulopathy
2. Use of anticoagulants with the exception of perioperative prophylactic administration of LMWH to prevent VTE
3. Known hypersensitivity to the active substance or to any of the excipients of IMP
4. History of deep vein thrombosis or pulmonary embolism
5. Pregnancy and lactation.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of a clinical trial is to assess the safety of perioperative infusion of Haemocomplettan P in scoliosis surgery in the paediatric population.;Secondary Objective: The secondary objective is to investigate the additional safety information, efficacy and feasibility of a prophylactic administration of fibrinogen in paediatric spinal surgery.;Primary end point(s): The primary objective of a clinical trial is to assess the safety of perioperative infusion of Haemocomplettan P in scoliosis surgery in the paediatric population. The following primary endpoint will be monitored to evaluate the primary objective:<br>1.) Incidence of any adverse events and reactions during participation in the study;Timepoint(s) of evaluation of this end point: will be evaluated at the end of the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary objective is to investigate the additional safety information, efficacy and feasibility of a prophylactic administration of fibrinogen in paediatric spinal surgery.<br>Secondary endpoints are as follows:<br>1.) Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI)<br>2.) Additional safety information<br>3.) Comparison of demographic characteristics between study groups<br>4.) Comparison of laboratory values of selected haematological parameters between study groups<br>5.) Comparison of blood loss level and its compensation between study groups<br>6.) Feasibility assessment<br>;Timepoint(s) of evaluation of this end point: Day 28