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Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery

NCT05391412 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-03-28

No results posted yet for this study

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.

Conditions

  • Fibrinogen
  • Spine Deformity
  • Coagulopathy, Consumption
  • Bleeding

Interventions

DRUG

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.

Sponsors & Collaborators

  • Brno University Hospital

    lead OTHER

Principal Investigators

  • Roman Gal, M.D., PhD. · Masaryk University Brno and University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-06
Primary Completion
2023-07-30
Completion
2023-09-30

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05391412 on ClinicalTrials.gov