Clinical Trials for Vascular Graft Thrombosis
There is currently 1 ongoing clinical trial investigating treatments for vascular graft thrombosis, specifically focusing on blood clot prevention in children who have received kidney transplants. This trial is examining how to optimize the dosing of enoxaparin, a medication used to prevent dangerous blood clots in transplanted organs.
Clinical trial locations
- France
Study on Adjusting Enoxaparin Dose for Children with Kidney Transplants to Prevent Blood Clots
This clinical trial is focused on preventing a serious complication called allograft vascular thrombosis, which occurs when blood clots form in the vessels of a transplanted kidney. This condition can reduce blood flow to the transplanted organ and affect how well it works, making prevention crucial for the success of kidney transplants in children.
Main inclusion criteria:
- Children between 2 and 18 years old who have received a kidney transplant
- Need for blood clot prevention treatment during the first week after transplant
- May have certain clotting disorders or risk factors, such as inherited conditions affecting blood clotting, genetic mutations like factor V Leiden or prothrombin mutation, history of blood clots, or situations where the donor kidney is from a very young child or has multiple blood vessels
- Legal guardian must sign consent and patient must have health insurance
Main exclusion criteria:
While specific exclusion criteria are not detailed in the source, the trial focuses on a specific group of pediatric kidney transplant recipients who need enoxaparin treatment, meaning children outside this defined group would not be eligible.
Focus and goal of the trial:
The main goal of this study is to find the best dose of enoxaparin for children who have had a kidney transplant. Enoxaparin is a medication that helps prevent blood clots by enhancing certain natural blood-thinning processes in the body. The study uses a special method called a Bayesian pharmacological approach to adjust the dose for each child individually. This approach aims to achieve the right level of medication in the blood—not too much, which could cause bleeding, and not too little, which might not prevent clots effectively. The target is to maintain anti-Xa activity (a measure of how well the medication is working) between 0.3 and 0.5 IU/mL, measured about 28-30 hours after starting treatment.
Investigational drug:
The trial is investigating enoxaparin sodium, a type of anticoagulant (blood thinner) classified as a low molecular weight heparin. It is given as a small injection under the skin and works by inhibiting factor Xa, a key component in the blood clotting process. The treatment will last for up to seven days, with regular monitoring to ensure safety and effectiveness. Throughout the study period, doctors will adjust the dose based on each child’s response to make sure the medication level stays within the target range.
Summary
Currently, there is only one clinical trial addressing vascular graft thrombosis, and it focuses specifically on pediatric kidney transplant recipients in France. This trial represents an important effort to improve outcomes for children who have received kidney transplants by optimizing blood clot prevention strategies. The study concentrates on personalized dosing of enoxaparin, using advanced methods to tailor treatment to each individual child’s needs. The focus on the pediatric population is particularly significant, as children may respond differently to medications compared to adults, and finding the right dose is crucial for both safety and effectiveness. The trial is expected to conclude by July 2025 and may provide valuable insights that could improve care standards for young transplant recipients.