drugset / Trial / NCT05391412
Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2022-06-06
- Primary completion
- 2023-07-30
- Completion
- 2023-09-30
Publications
- Hudec J, Vrbica K, Hrdy O, Galko M, Repko M, Stepanova R, Demlova R, Kubelova M, Gal R. Effect of prophylactic fibrinogen concentrate in scoliosis surgery (EFISS): a randomised pilot trial. BMJ Open. 2025 Oct 7;15(10):e100137. doi: 10.1136/bmjopen-2025-100137.
- Vrbica K, Hudec J, Hrdy O, Galko M, Horalkova H, Demlova R, Kubelova M, Repko M, Gal R. Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (EFISS): a study protocol of two-arm, randomised trial. BMJ Open. 2023 May 26;13(5):e071547. doi: 10.1136/bmjopen-2022-071547.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fibrinogen Concentrate Human | Protein / enzyme biologic | 20 mg/kg | Intravenous |
| Subject | Fibrinogen Concentrate Human | Protein / enzyme biologic | 30 mg/kg | Intravenous |