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RECRUITING

NCT06934278

PHASE3

Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis

Sponsor: Turku University Hospital

View on ClinicalTrials.gov

Summary

OCTAGON trial is a randomized, double-blinded, parallel-group non-inferiority multicenter (Helsinki and Turku University Hospitals, Finland) clinical trial according to CONSORT criteria. 194 adolescents with idiopathic (major curve \> 45 degrees) or neuromuscular scoliosis (major curve \> 50 degrees) are enrolled for the OCTAGON trial comparing pooled human plasma (Octaplas, 10mL/kg, active management) vs. Plasmalyte (10 mL/kg, placebo) before incision as part of the normal intraoperative fluid therapy. Data is collected at baseline and at each follow-up until a minimum of 2-year follow-up. Outcomes Outcomes for the OCTAGON trial include 1) intraoperative blood loss (in mL, primary outcome) and the need for allogenic red blood cell infusion (percentage of patients). Secondary outcomes include health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain (48-hour opioid consumption), operative time (hours), drain output (mL), hidden blood loss (mL), hospital stay, and complications (skin reactions, TRALI, deep surgical site infection, neurologic deficit). Research questions and hypothesis Does prophylactic use of pooled human plasma decrease intraoperative blood loss in adolescents undergoing instrumented spinal fusion for scoliosis? We hypothesize that pooled human plasma will reduce intraoperative and total blood loss by 25% resulting in lower need for blood transfusion and fewer surgical site infections. Objectives To compare the effect of pooled human plasma vs. crystalloid fluids on intraoperative bleeding and total blood loss (drain output and hidden blood loss) in children undergoing posterior spinal fusion for AIS and NMS. Adverse events will be recorded and reported as minor (skin reaction) or major (severe allergic reaction, transfusion related acute lung injury, TRALI, deep surgical site infection, neurologic injury). Ethical aspects The PHP trial has been evaluated via European regulatory authority (EU CT: 2024-514857-31-00) and by Fimea (FIMEA/2024/006588). Informed consent is obtained from the parent(s). Results will be disseminated in high-quality peer-reviewed publications. The individual patient safety and high-quality management of fractures and scoliosis is a priority in this trial. The randomization can be opened at any stage of the treatment process. Based on the clinical decision the randomized treatment can be terminated and treatment provided accord-ing to clinical decision making even if results will be evaluated using the intention to treat princi-ple. Pain management will be prioritized in every clinical scenario and parental presence is always possible.

Official title: Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis: A Double-Blind, Randomized Clinical Trial

Key Details

Gender

All

Age Range

10 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

194

Start Date

2025-05-02

Completion Date

2030-12-31

Last Updated

2025-05-07

Healthy Volunteers

Conditions

Adolescent Idiopathic Scoliosis (AIS)Neuromuscular Scoliosis

Interventions

DRUG

Pooled human plasma

Infusion of pooled human plasma (Octaplas, 10 mL/kg, max 400 mL) over 1 hour after induction of general anaesthesia

DRUG

Placebo

Infusion of cryst (Octaplas, 10 mL/kg, max 400 mL) over 1 hour after induction of general anaesthesia

Inclusion Criteria: * Written informed consent. * Aged between 10 and 21 years of age * Scoliosis requiring posterior scoliosis surgery using all pedicle screw technique for AIS (\>45-degree major curve) or NMS (\>50-degree major curve) * Normal whole spine MRI except for the spinal deformity (only for patients with adolescent idiopathic scoliosis as patients with neuromuscular scoliosis do not typically undergo MR images as they would need general anaesthesia) Exclusion Criteria: * Immunoglobulin A-deficiency * Need for anteroposterior surgery * Need for three column vertebral resection * Smoking * Diabetes mellitus * Abnormalities in blood coagulation (thromboplastin time below above or below of normal values, 70-130%) * Blood trombosytes less than 150 x E9/l * Body mass index over 40 * Allergy or hypersensitivity to study medications or their ingredients * Pregnancy or breast-feeding, aim of becoming pregnant during the study. * Participation in another study and receipt of any other investigational agent during 2 year period of current investigation * Inability to provide written informed consent * Any significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study. * A history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements. * Known history of, or documented positive hepatitis B or C or HIV infection Prior or concurrent malignancy * Aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 3 x upper-limit of normal * Creatinine clearance (CrCl) \< 60 ml/min measured by 24-hour urine collection or estimated from the Cockcroft and Gault formula * Clinically significant ECG findings as judged by the investigator * Amiodarone medication * Hyperkalemia * Renal insufficiency * AV-block * Metabolic or respiratory alkalosis * Hypochlorhydria * Hypersensitivity for active component or additives.

Locations (2)

Helsinki University Hospital

Helsinki, Finland

Turku University Hospital

Turku, Finland