Ongoing Clinical Trials for Scoliosis
Currently, there is 1 ongoing clinical trial for scoliosis, focusing on improving fluid management during spinal fusion surgery in children and adolescents. This trial is being conducted in Finland and compares two different types of intravenous solutions to reduce blood loss during the surgical procedure.
Clinical trial locations
Study on Human Plasma Protein vs. Crystalloid for Fluid Management in Children with Scoliosis Undergoing Spinal Fusion Surgery
This clinical trial is investigating the best way to manage fluids during surgery for children who have a curved spine. The study compares two different types of intravenous solutions given to patients during spinal fusion surgery, a procedure aimed at straightening the spine.
Who can participate:
- Children and young people aged between 10 and 21 years
- Those diagnosed with either adolescent idiopathic scoliosis (where the cause of the spine curve is unknown and occurs in teenagers) or neuromuscular scoliosis (spine curve caused by nerve or muscle problems)
- Patients with a spine curve greater than 45 degrees
- Those scheduled for posterior spinal fusion surgery using the pedicle screw technique
- Both males and females are eligible
Who cannot participate:
- Patients with types of scoliosis other than adolescent idiopathic scoliosis or neuromuscular scoliosis
- Those outside the specified age range of 10 to 21 years
What the trial involves:
The main goal of this study is to determine which fluid solution is more effective in reducing blood loss during spinal fusion surgery. Participants will be randomly assigned to receive one of two solutions: octaplasLG, which contains human plasma protein, or Plasma-Lyte® 148, a crystalloid solution containing various substances including magnesium chloride, potassium chloride, sodium chloride, sodium acetate, and sodium gluconate. The study is double-blind, meaning neither the patients nor the medical team will know which solution is being given, ensuring unbiased results.
During surgery, the assigned solution will be delivered directly into the bloodstream through an intravenous infusion. Researchers will carefully monitor several outcomes, including the amount of blood lost during the operation, whether additional blood transfusions are needed, pain levels after surgery, and how long patients stay in the hospital. The trial aims to provide important information about the best practices for fluid management in children undergoing spinal surgery.
Investigational drugs being tested:
OCTAPLAS is a pooled human plasma product that contains important blood proteins to help with clotting and reduce bleeding during surgery. PLASMALYTE is a crystalloid solution used to maintain fluid balance in the body. Both are administered intravenously, and the trial will compare their effectiveness in managing blood loss and supporting recovery.
Summary
Currently, there is only one active clinical trial for scoliosis, taking place in Finland. This trial focuses specifically on improving surgical outcomes for young patients undergoing spinal fusion surgery by comparing two different fluid management approaches. The study addresses an important aspect of surgical care—reducing blood loss during the procedure—which can significantly impact recovery and overall outcomes. The trial is open to both children with adolescent idiopathic scoliosis and those with neuromuscular scoliosis, making it relevant for a broad range of young patients requiring this type of surgery.