Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery

• Status: Not yet recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

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 monocentric and will be conducted in University Hospital Brno, Czech Republic. This is a pilot study in which the primary objective will be to evaluate the feasibility of a clinical trial in 32 selected patients undergoing scoliosis surgery. Participants will be randomized into study groups in a 1:1 allocation ratio and followed up for 28 days after surgery. The expected duration of this clinical trial is 8 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brno University Hospital

Criteria

Inclusion Criteria:

Subjects will be eligible for the trial if they meet all of the following criteria:

1. Age < 18 years of age at the time of enrolment

2. Elective scoliosis surgery

3. Signed the relevant informed consent form (more in Chapter 10.1)

4. Sexually active participants (≥ 15 years old) must agree to the use of following methods of contraception for the duration of this clinical trial:

1. 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.

2. Men - sexual abstinence or the use of an adequate contraceptive method (i.e. condom) in case of sexual intercourse.

Exclusion Criteria:

Subjects will not be eligible for the trial if they meet any of the following criteria:

1. Diagnosed congenital or acquired coagulopathy

2. Use of anticoagulants with the exception of perioperative prophylactic administration of Low molecular weight heparin (LMWH) to prevent venous thromboembolism (VTE)

3. Known hypersensitivity to the active substance or to any of the excipients of Investigational Medicinal Product (IMP)

4. History of deep vein thrombosis or pulmonary embolism

5. Pregnancy and lactation