Study on Human Plasma Protein vs. Crystalloid for Fluid Management in Children with Scoliosis Undergoing Spinal Fusion Surgery

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What is this study about?

This clinical trial is focused on studying the management of fluids in children who are undergoing surgery for scoliosis, a condition where the spine curves sideways. The study involves two types of treatments: a solution called octaplasLG, which contains human plasma protein, and another solution known as Plasma-Lyte® 148, which includes a mix of substances like magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, and sodium gluconate. These solutions are given through an intravenous infusion, which means they are delivered directly into the bloodstream.

The purpose of the study is to compare the effectiveness of these two solutions in reducing blood loss during surgery for children with adolescent idiopathic scoliosis or neuromuscular scoliosis. Participants in the study will be randomly assigned to receive either the octaplasLG solution or the Plasma-Lyte® 148 solution. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which solution is being administered to each participant, to ensure unbiased results.

Throughout the study, researchers will monitor various outcomes, including the amount of blood lost during surgery, the need for additional blood transfusions, and the overall recovery experience, such as pain levels and hospital stay duration. The study aims to provide valuable insights into the best fluid management practices for children undergoing spinal surgery for scoliosis.

1 joining the study

Participation begins after meeting the criteria: age between 10 and 21 years, diagnosed with scoliosis, and scheduled for posterior spinal fusion surgery using the pedicle screw technique.

2 preparation for surgery

Before surgery, the patient will be randomly assigned to receive either OCTAPLAS or PLASMALYTE during the procedure. This assignment is double-blind, meaning neither the patient nor the medical team will know which solution is administered.

3 surgery and infusion

During the spinal fusion surgery, the assigned solution will be administered through an intravenous infusion. The purpose is to manage fluid levels and reduce blood loss during the operation.

4 postoperative monitoring

After surgery, the primary focus is on measuring blood loss until the wound is closed. Secondary observations include the need for additional blood transfusions, pain levels, and overall recovery.

5 recovery and follow-up

Postoperative recovery involves monitoring for complications, assessing pain management, and evaluating the patient’s quality of life using a specific questionnaire. The duration of hospital stay and any additional interventions will also be recorded.

Who Can Join the Study?

The patient must have scoliosis, which is a condition where the spine curves sideways.
The patient should be between 10 to 21 years old.
The patient must be undergoing a surgery called posterior spinal fusion for scoliosis. This is a procedure to help straighten the spine.
The type of scoliosis should be either adolescent idiopathic scoliosis (AIS), which means the cause of the spine curve is unknown and it occurs in teenagers, or neuromuscular scoliosis (NMS), which is related to nerve and muscle conditions.
The spine curve should be more than 45 degrees.
The surgery should use a method called the pedicle screw technique, which involves placing screws in the spine to help correct the curve.
Both male and female patients can participate.
The study includes patients who might be considered vulnerable, meaning they may need extra care or protection.

Who Cannot Join the Study?

Patients with conditions other than neuromuscular scoliosis (NMS) or adolescent idiopathic scoliosis (AIS) cannot participate. Neuromuscular scoliosis is a type of spine curve caused by nerve or muscle problems. Adolescent idiopathic scoliosis is a spine curve that appears in teenagers without a known cause.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it is important to be within the required age group.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are not considered part of a vulnerable population may not be eligible. A vulnerable population includes groups like children or those with certain health conditions who may need special protection in research.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Turku University Hospital	Turku	Finland
Huwkdbhm Uttqbprmdk Cnldmvr Hhosbmzr	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Recruiting	01.09.2024

Trial locations

Investigated drugs:

OCTAPLAS is a type of pooled human plasma used in this clinical trial. It is being tested to see if it can help reduce blood loss during surgery for children undergoing spinal fusion for scoliosis. Plasma is a component of blood that contains important proteins and can help with blood clotting and other functions.

PLASMALYTE is a crystalloid solution used in the trial as a comparison to OCTAPLAS. Crystalloids are fluids that are often used to maintain fluid balance in the body during surgery. This solution is being used to see how it compares to OCTAPLAS in terms of reducing blood loss during the surgical procedure.

Investigated diseases:

Neuromuscular scoliosis

Neuromuscular scoliosis – This condition is a type of scoliosis that occurs due to disorders affecting the muscles and nerves. It often develops in individuals with conditions like cerebral palsy or muscular dystrophy. The spine curves sideways, and the progression can vary depending on the underlying neuromuscular disorder. As the condition progresses, it may lead to an imbalance in the trunk and pelvis, affecting posture and mobility. The severity of the curve can increase over time, especially during growth spurts. Management often focuses on maintaining function and preventing further curvature.

Adolescent idiopathic scoliosis – This is a common form of scoliosis that appears in children during their growth spurt just before puberty. The cause is unknown, hence the term “idiopathic.” It is characterized by a lateral curvature of the spine, which can range from mild to severe. The progression of the curve can vary, with some cases remaining stable while others worsen as the child grows. The condition is often detected during routine physical exams or school screenings. Monitoring is essential to assess changes in the curvature over time.

Trial ID:

2024-514857-31-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Human Plasma Protein vs. Crystalloid for Fluid Management in Children with Scoliosis Undergoing Spinal Fusion Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?