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Compares treatment options for Adolescent Idiopathic Scoliosis (AIS)
Official title Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis
ClinicalTrials.gov ID: NCT06934278
What this study is testing
What is Pooled human plasma?
Pooled human plasma is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for adolescent idiopathic scoliosis (ais).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 21
You may be able to join if
- 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...
You likely can't join if
- 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%)
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
- Turku, Finland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland; Turku, Finland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.