Status:
UNKNOWN
Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery
Lead Sponsor:
Brno University Hospital
Conditions:
Fibrinogen
Spine Deformity
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE4
Brief Summary
EFISS is a prospective, randomized, placebo-controlled trial testing the feasibility, safety and efficacy of prophylactic administration of fibrinogen in paediatric spinal surgery. The study is monoce...
Detailed Description
Scoliosis is an abnormal lateral curvature of the spine. It is most commonly diagnosed in childhood and early adolescence. Surgical treatment is indicated for severe scoliosis to reduce back pain, neu...
Eligibility Criteria
Inclusion
- Subjects will be eligible for the trial if they meet all of the following criteria:
- Age \< 18 years of age at the time of enrolment
- Elective scoliosis surgery
- Signed the relevant informed consent form (more in Chapter 10.1)
- Sexually active participants (≥ 15 years old) must agree to the use of following methods of contraception for the duration of this clinical trial:
- 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.
- Men - sexual abstinence or the use of an adequate contraceptive method (i.e. condom) in case of sexual intercourse.
Exclusion
- Subjects will not be eligible for the trial if they meet any of the following criteria:
- Diagnosed congenital or acquired coagulopathy
- Use of anticoagulants with the exception of perioperative prophylactic administration of Low molecular weight heparin (LMWH) to prevent venous thromboembolism (VTE)
- Known hypersensitivity to the active substance or to any of the excipients of Investigational Medicinal Product (IMP)
- History of deep vein thrombosis or pulmonary embolism
- Pregnancy and lactation
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05391412
Start Date
June 6 2022
End Date
September 30 2023
Last Update
March 28 2023
Active Locations (1)
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1
University Hospital Brno
Brno, Czechia, 625 00