Ongoing Clinical Trials for Perthes Disease
There is currently 1 ongoing clinical trial investigating treatment approaches for Perthes disease. This trial is focused on reducing blood loss during hip surgery in children using tranexamic acid. (Also known as: Legg-Calvé-Perthes Disease, LCPD)
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 investigating whether tranexamic acid can effectively reduce blood loss during hip surgery in children with various hip conditions, including Legg-Calvé-Perthes Disease. The study is being conducted in the Netherlands and focuses on children who require specific types of hip bone surgery.
Main inclusion criteria:
- Children between 1 and 18 years old
- Need for hip bone surgery involving either the upper part of the thigh bone (proximal femoral osteotomy), surgery of the hip socket (pelvic osteotomy), or both
- Surgery can be needed for various conditions including slipped growth plate, hip joint development problems, or muscle and nerve conditions affecting the hip
- Both male and female patients are eligible
- Must be scheduled for surgery at the study hospital
- Parent or legal guardian consent is required for patients under the age of consent
Main exclusion criteria:
- History of blood clotting disorders or active bleeding problems
- Current use of blood-thinning medications
- Known allergies to tranexamic acid or similar medications
- Severe kidney or liver disease
- History of seizures or epilepsy
- Blood transfusions received within the last 3 months
- Uncontrolled high blood pressure
- Color vision deficiency
- Current urinary tract bleeding
- Participation in other clinical trials
- Inability to comply with study follow-up requirements
Focus and goal of the trial:
The primary focus of this study is to determine whether tranexamic acid can help reduce blood loss during hip surgery in children. During operations involving cuts in the hip bones to improve their position and function, blood loss can occur. This trial aims to measure and compare blood loss between patients who receive tranexamic acid and those who receive a placebo (saline solution).
The study follows a structured timeline. Before surgery, patients are randomly assigned to receive either tranexamic acid or saline through an intravenous injection. Medical staff take blood samples to measure baseline blood values, including hemoglobin levels. On the day of surgery, the assigned medication is given before the procedure begins, and the medical team carefully monitors and records blood loss throughout the operation. After surgery, additional blood samples are taken, and patients are monitored for any complications or need for blood transfusions. The hospital stay duration is also documented as part of the study data.
Investigational drugs:
The main medication being tested is tranexamic acid, which helps reduce bleeding during surgery by preventing blood clots from breaking down too quickly. This allows better control of blood loss during surgical procedures. Tranexamic acid is given intravenously before surgery and has been used safely in both adults and children for managing surgical bleeding, particularly in orthopedic procedures like hip surgeries.
The comparison group receives a placebo, which is an inactive saline solution containing no medication. This allows researchers to accurately measure how effective tranexamic acid is at reducing blood loss compared to no active treatment.
Summary
Currently, there is one active clinical trial available for patients with Perthes disease, located in the Netherlands. This trial addresses an important aspect of surgical care for children with this condition: managing blood loss during hip surgery. The study is part of a broader investigation that includes children with various hip conditions requiring similar surgical procedures.
The trial focuses specifically on the use of tranexamic acid, a medication already established in medical practice for controlling bleeding during surgery. The research aims to provide evidence on its effectiveness specifically in pediatric hip surgeries, which could help improve surgical outcomes and recovery for children with Perthes disease and related hip conditions.
Patients interested in this trial should discuss eligibility with their treating physician, particularly regarding the exclusion criteria related to bleeding disorders, kidney function, and medication use.