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Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery
Sponsor: Brno University Hospital
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.
Official title: Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery: A Randomized Pilot Study
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2022-06-06
Completion Date
2023-07-11
Last Updated
2026-10-16
Healthy Volunteers
No
Interventions
Fibrinogen Concentrate Human
Patients in the intervention group will receive single administration of fibrinogen concentrate intravenously at a dose of 20-30 mg/kg (depending on body weight and clinical condition, according to SmPC). The medicinal product will be diluted in a 100 ml infusion bag and administered after induction of anaesthesia prior beginning of surgery. The infusion rate should not exceed approximately 5 ml per minute.
Locations (1)
University Hospital Brno
Brno, Czechia