Ongoing Clinical Trials for Neuromuscular Scoliosis
There is currently 1 ongoing clinical trial focused on neuromuscular scoliosis. This trial is investigating fluid management strategies during spinal fusion surgery for children with scoliosis, comparing a human plasma protein solution with a crystalloid solution to reduce blood loss during the 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 examining how best to manage fluids during surgery for children with scoliosis, a condition where the spine curves sideways. The study compares two different types of intravenous solutions given during spinal fusion surgery to help reduce blood loss.
Who can participate:
- Children and young adults between 10 and 21 years old
- Patients diagnosed with either neuromuscular scoliosis (caused by nerve or muscle problems) or adolescent idiopathic scoliosis (when the cause of the spine curve is unknown)
- Those scheduled for posterior spinal fusion surgery using the pedicle screw technique
- Patients with a spine curve of more than 45 degrees
- Both male and female patients are eligible
Who cannot participate:
- Patients with types of scoliosis other than neuromuscular or adolescent idiopathic scoliosis
- Those outside the specified age range of 10 to 21 years
What the trial involves:
The main goal of this study is to compare the effectiveness of two different solutions in reducing blood loss during spinal fusion surgery. Participants will be randomly assigned to receive either OCTAPLAS, a solution containing human plasma protein, or Plasma-Lyte 148, a crystalloid solution containing a mix of electrolytes and other substances.
The study is designed as a double-blind trial, which means neither the participants nor the medical team will know which solution is being given during the surgery. This helps ensure the results are unbiased and reliable.
During the surgery, researchers will carefully monitor the amount of blood lost until the surgical wound is closed. They will also track whether additional blood transfusions are needed, pain levels after surgery, the overall recovery experience, and how long patients need to stay in the hospital. Quality of life will be assessed using a specific questionnaire.
The investigational solutions:
OCTAPLAS is a pooled human plasma product that contains important blood proteins. These proteins help with blood clotting, which may reduce bleeding during surgery. It is given through an intravenous infusion directly into the bloodstream.
Plasma-Lyte 148 is a crystalloid solution that helps maintain fluid balance in the body during surgery. It contains magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, and sodium gluconate. This solution is also given intravenously and serves as a comparison to OCTAPLAS in terms of reducing blood loss.
Summary
Currently, only one clinical trial is actively recruiting patients with neuromuscular scoliosis. This trial is taking place in Finland and focuses specifically on improving surgical outcomes for children undergoing spinal fusion. The study addresses an important aspect of surgical care—managing blood loss—which can significantly impact recovery and the need for blood transfusions.
The trial compares two different approaches to fluid management: a plasma-based solution (OCTAPLAS) and a crystalloid solution (Plasma-Lyte 148). The results of this research may help doctors determine which type of fluid therapy is more effective in reducing complications and improving outcomes for young patients undergoing this complex surgical procedure.
For families considering participation, this trial offers an opportunity to contribute to medical knowledge while receiving care as part of a carefully monitored research protocol. The trial is open to both children with neuromuscular scoliosis and those with adolescent idiopathic scoliosis, providing a broader understanding of fluid management across different types of spinal curvature.
