Clinical trial • Phase IV • Musculoskeletal

Human plasma protein for Neuromuscular scoliosis | Adolescent idiopathic scoliosis

Phase IV trial of Human plasma protein for Neuromuscular scoliosis | Adolescent idiopathic scoliosis.

Overview

Trial Therapeutic Area: Musculoskeletal
Trial Disease: Neuromuscular scoliosis | Adolescent idiopathic scoliosis
Trial Stage: Phase IV
Drug Modality: Small molecule | Peptide/protein/enzyme
Paediatric Trial: Yes

Key dates

Initial CTIS Submission Date: 01-08-2024
First CTIS Authorization Date: 12-11-2024

Trial design

Randomised, plasma-lyte® 148 (comparator) — solution for infusion (intravenous infusion). dose uom reported as millilitre(s)/kilogram with max total dose amount 10 millilitre(s)/kilogram. octaplaslg (test) — solution for infusion (intravenous infusion). dose uom reported as millilitre(s)/kilogram with max total dose amount 10 millilitre(s)/kilogram. exact intraoperative dosing schedule beyond route and dose uom not specified.-controlled Phase IV trial across 2 sites in Finland.

Randomised: Yes
Comparator: Plasma-Lyte® 148 (comparator) — solution for infusion (intravenous infusion). Dose UOM reported as millilitre(s)/kilogram with max total dose amount 10 millilitre(s)/kilogram. octaplasLG (test) — solution for infusion (intravenous infusion). Dose UOM reported as millilitre(s)/kilogram with max total dose amount 10 millilitre(s)/kilogram. Exact intraoperative dosing schedule beyond route and dose UOM not specified.
Target Sample Size: 90

Eligibility

Recruits 90 paediatric patients.

Vulnerable Population: Vulnerable population selected: children/adolescents. Study population includes participants aged 10 to 21 years. Subject information and informed consent forms are provided for: subjects 18y and older; parents of subjects under 18y; legal representatives of subjects; subjects 10-14y old; subjects 15-17y old; and a subjects plain language document. Consent will therefore involve parents/legal representatives for minors and age-appropriate subject information/assent forms for 10-14 and 15-17 year olds; subjects 18+ provide their own consent. (Documents listed: L1_SIS and ICF_Octaplas_subjects 18y and older; L1_SIS and ICF_Octaplas_parents of subjects under 18y; L1_SIS and ICF_Octaplas_legal representatives of subjects; L1_SIS and ICF_Octaplas_subjects 10-14y old; L1_SIS and ICF_Octaplas_subjects 15-17y old; L1_SIS and ICF_Octaplas_subjects plain language).

Inclusion criteria

{"criterion_text":"-Scoliosis patients (aged 10 to 21 years of age) undergoing posterior spinal fusion for adolescent idiopathic scoliosis or neuromuscular scoliosis (>45 degrees) using pedicle screw technique."}

Exclusion criteria

{"criterion_text":"-Coagulation disorder, smoking, unwilling to consent, vertebral column resection, need for anteroposterior surgery and body mass index over 40."}

Endpoints

Primary endpoints

{"endpoint_text":"-Primary outcome is the intraoperative blood loss (blood loss in mL after wound closure).","definition_or_measurement_approach":"Intraoperative blood loss measured in mL after wound closure."}

Secondary endpoints

{"endpoint_text":"-Secondary outcomes include need for allogenic red blood cell infusion (percentage of patients at hospital release, health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain (48-hour opioid consumption, pain visual analogue score), operative time (hours), drain output (mL), hidden blood loss (mL), hospital stay, and complications (skin reactions, TRALI, deep surgical site infection).","definition_or_measurement_approach":"Composite of specified measures: need for allogenic RBC infusion (percentage at hospital release); health-related quality of life measured by Scoliosis Research Society 24 questionnaire; postoperative pain assessed by 48-hour opioid consumption and pain visual analogue score; operative time in hours; drain output in mL; hidden blood loss in mL; length of hospital stay; and recorded complications including skin reactions, TRALI, and deep surgical site infection."}

Recruitment

Planned Sample Size: 90
Recruitment Window Months: 64
Consent Approach: Informed consent documented with age-specific materials: separate subject information and ICFs for subjects 18y and older, parents of subjects under 18y, legal representatives, subjects 10-14y, subjects 15-17y, and a plain language subject information document. Languages available include Finnish and Swedish (patient-facing documents labelled FI and SVE). For minors consent is obtained from parents/legal representatives with age-appropriate assent/information for the child; subjects 18+ provide their own consent.

Geography

Total Number Of Sites: 2
Total Number Of Participants: 90

Finland

Earliest CTIS Part Ii Submission Date: 11-10-2024
Latest Decision Or Authorization Date: 16-01-2025
Processing Time Days: 97
Number Of Sites: 2
Number Of Participants: 90

Sites

Site Name: HUS-Yhtymae
Department Name: Department of Pediatric Orthopedics and Traumatology
Principal Investigator Name: Matti Ahonen
Principal Investigator Email: matti.ahonen@hus.fi
Contact Person Name: Matti Ahonen
Contact Person Email: matti.ahonen@hus.fi

Site Name: Turku University Hospital
Department Name: Anesthesiology and Intensive Care, Lighthouse Hospital
Principal Investigator Name: Linda Helenius
Principal Investigator Email: linda.helenius@tyks.fi
Contact Person Name: Linda Helenius
Contact Person Email: linda.helenius@tyks.fi

Sponsor

Primary sponsor

Full Name: HUS-Yhtymae
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Finland

Investigational products

Investigational Product Name: octaplasLG infuusiokuiva-aine ja liuotin, liuosta varten
Active Substance: Human plasma protein
Modality: Peptide/protein/enzyme
Routes Of Administration: INTRAVENOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised (marketing authorisation number 40471)
Starting Dose: up to 10 millilitre(s)/kilogram
Maximum Dose: 10 millilitre(s)/kilogram

Investigational Product Name: Plasma-Lyte® 148 (pH 7.4) solution for infusion.
Active Substance: magnesium chloride hexahydrate; potassium chloride; sodium chloride; sodium acetate trihydrate; sodium gluconate
Modality: Small molecule
Routes Of Administration: INTRAVENIOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised (marketing authorisation number PL 00116/0332)
Starting Dose: up to 10 millilitre(s)/kilogram
Maximum Dose: 10 millilitre(s)/kilogram

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