💬In plain words
What the trial is, and whether it could suit you
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), postoper
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📋 Eligibility rules (as published)
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.
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