Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery

NCT05391412 | Unknown Phase 4 DMC

• 1 other identifier: CT0012022
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 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

Keywords

fibrinogen; scoliosis; coagulopathy

Outcome Measures

Primary Outcomes (5)

• Adverse event

  The following primary endpoint will be monitored to evaluate the primary objective: Adverse event - Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  through study completion, an average of 6 months

• Adverse drug reaction

  The following primary endpoint will be monitored to evaluate the primary objective: Adverse drug reaction - All untoward and unintended responses to an investigational medicinal product related to any dose administered

  through study completion, an average of 6 months

• Serious adverse event and reaction

  The following primary endpoint will be monitored to evaluate the primary objective: Serious adverse event and reaction - A serious adverse event/reaction is any untoward medical occurrence or effect that at any dose: * Results in death; * Is life-threatening; * Requires hospitalization or extension of existing hospitalization; * Results in persistent or significant disability or incapacity; * Is a congenital anomaly or birth defect

  through study completion, an average of 6 months

• Unexpected adverse reaction

  The following primary endpoint will be monitored to evaluate the primary objective: Unexpected adverse reaction - Adverse reaction, the nature, severity, or outcome of which

  through study completion, an average of 6 months

• Suspected unexpected serious adverse reaction

  The following primary endpoint will be monitored to evaluate the primary objective: Suspected unexpected serious adverse reaction - Any suspected adverse reaction related to the study treatment that is both serious and unexpected.

  through study completion, an average of 6 months

Secondary Outcomes (35)

• Deep-vein thrombosis

  through study completion, an average of 6 months

• Pulmonary embolism

  through study completion, an average of 6 months

• Infection or healing disorder

  through study completion, an average of 6 months

• Length of stay

  through study completion, an average of 6 months

• ICU length of stay

  through study completion, an average of 6 months

Study Arms (2)

Fibrinogen group

EXPERIMENTAL

The fibrinogen concentrate (20-30mg/kg, max 2g) will be administered in 100ml (Aqua pro injection) intravenously to the patient.

Drug: Fibrinogen Concentrate Human

Control group

NO INTERVENTION

Patients in the control group will not receive any additional medication than standard of care.

Interventions

Fibrinogen Concentrate Human DRUG

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.

Also known as: HAEMOCOMPLETTAN P

Fibrinogen group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital Brno

Brno, 625 00, Czechia

RECRUITING

Related Publications (2)

• 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.

  PMID: 41062134 DERIVED

• 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.

  PMID: 37236666 DERIVED

MeSH Terms

Conditions

Disseminated Intravascular Coagulation; Hemorrhage; Scoliosis; Hemostatic Disorders

Interventions

Fibrinogen

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Thrombophilia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors

Study Officials

• Roman Gal, M.D., PhD.

  Masaryk University Brno and University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roman Gal, prof.

CONTACT

532233850; gal.roman@fnbrno.cz

Ondrej Hrdy, MD

CONTACT

532232305; hrdy.ondrej@fnbrno.cz

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 26, 2022
• Study Start: June 6, 2022
• Primary Completion: July 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)