Status:
RECRUITING
Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis
Lead Sponsor:
Turku University Hospital
Collaborating Sponsors:
Helsinki University Central Hospital
Conditions:
Adolescent Idiopathic Scoliosis (AIS)
Neuromuscular Scoliosis
Eligibility:
All Genders
10-21 years
Phase:
PHASE3
Brief 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 adolesce...
Detailed Description
Introduction Total blood loss including intraoperative, drain output, and hidden blood loss equals to 40% of blood volume in patients undergoing posterior spinal fusion for paediatric spinal deformiti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT06934278
Start Date
May 2 2025
End Date
December 31 2030
Last Update
May 7 2025
Active Locations (2)
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1
Helsinki University Hospital
Helsinki, Finland, FI-00029
2
Turku University Hospital
Turku, Finland, 20900