Ongoing Clinical Trials for Developmental Hip Dysplasia
Currently, there is 1 ongoing clinical trial investigating treatment approaches for developmental hip dysplasia and related hip conditions in children. This trial is evaluating a medication called tranexamic acid to reduce blood loss during hip surgery. The study is being conducted in the Netherlands and involves children aged 1 to 18 years who require hip bone surgery.
Clinical trial locations
A study of tranexamic acid to reduce blood loss during hip surgery in children with hip dysplasia and other hip conditions
This clinical trial is examining whether tranexamic acid can effectively reduce blood loss during hip surgery in children with developmental hip dysplasia and other related hip conditions. The study focuses on surgical procedures called proximal femoral osteotomy and pelvic osteotomy, which involve making controlled cuts in the hip bones to improve their position and function.
Main focus and goal: The primary aim of this study is to determine whether tranexamic acid, a medication that helps control bleeding, can reduce the amount of blood lost during hip surgery in children. The trial will compare outcomes between children who receive tranexamic acid and those who receive a placebo (inactive saline solution). The medication is given through an injection into a vein before surgery begins. Doctors will measure blood loss during the operation and monitor patients’ recovery to assess the medication’s effectiveness.
Who can participate: Children and adolescents between 1 and 18 years of age may be eligible for this study if they need hip bone surgery. This includes surgery of the upper part of the thigh bone, surgery of the hip socket, or both. The surgery may be needed for various reasons including slipped growth plate in the hip, hip joint development problems, or muscle and nerve conditions affecting the hip. Both boys and girls can participate. For younger children, a parent or legal guardian must provide consent for participation.
Who cannot participate: Children are not eligible for this study if they have a history of blood clotting disorders or are currently taking blood-thinning medications. Those with known allergies to tranexamic acid or similar medications cannot participate. Other exclusion factors include active bleeding disorders, severe kidney or liver problems, history of seizures, current urinary tract bleeding, or color vision deficiency. Children who received blood transfusions within the last three months or have uncontrolled high blood pressure are also excluded. Additionally, those participating in other clinical trials or unable to comply with study follow-up requirements cannot join.
Investigational medications: The study uses two substances:
- Tranexamic acid: This medication helps reduce bleeding during surgery by preventing blood clots from breaking down too quickly. It is given before surgery through an intravenous line and has been used safely in both adults and children to manage surgical bleeding.
- Placebo: An inactive saline solution that contains no medication. This is used as a comparison to measure how effective tranexamic acid is at reducing blood loss.
What to expect during the study: Participation begins with preparation for hip surgery. Before the operation, patients are randomly assigned to receive either tranexamic acid or saline through an intravenous injection. Medical staff will take blood samples before surgery to measure baseline blood values. On the day of surgery, the assigned medication is given before the procedure begins, and the medical team monitors and records blood loss during the operation. After surgery, additional blood samples are taken to check blood values, and doctors monitor for any complications. The study concludes after hospital discharge and final blood tests.
Summary
Currently, there is one active clinical trial addressing developmental hip dysplasia and related hip conditions in children. This trial is being conducted in the Netherlands and focuses on reducing surgical blood loss using tranexamic acid during hip bone surgery. The study involves children between 1 and 18 years of age who require proximal femoral or pelvic osteotomy procedures. The research aims to determine whether this well-established medication can safely and effectively reduce bleeding during these complex orthopedic procedures, potentially improving surgical outcomes and reducing the need for blood transfusions in pediatric patients.