Ongoing Clinical Trials for Meningorrhagia
Currently, there is 1 ongoing clinical trial investigating treatment options for patients with meningorrhagia (also known as meningeal hemorrhage). This trial is being conducted in France and focuses on preventing complications in patients with brain injuries who require opioid pain medications while in intensive care.
Clinical trial locations
Study on Naloxegol to Prevent Constipation in Patients with Brain Injury and Opioid Use
This clinical trial is investigating patients who have experienced head trauma or meningeal hemorrhage, a type of bleeding in the protective layers covering the brain and spinal cord. These serious brain injuries often require intensive care treatment with strong pain medications called opioids, which can cause significant digestive problems.
Inclusion criteria: To participate in this trial, patients must be at least 18 years old and admitted to an intensive care unit specifically for head trauma or subarachnoid hemorrhage (a type of bleeding in the space around the brain) without other life-threatening injuries. Participants must be receiving sedation for brain protection using specific pain-relief medications such as Sufentanil, Fentanyl, Remifentanil, or Morphine, administered through a vein for less than 24 hours. They must also be expected to need mechanical ventilation and sedation for at least 48 hours, have plans for monitoring the pressure inside the skull, and be scheduled to receive feeding through a tube into the stomach. Patients must be affiliated with or benefiting from a social security scheme.
Exclusion criteria: Patients cannot participate if they have a previous history of head trauma that might have affected the brain. Those with gastrointestinal motility disorders, which are problems with how food moves through the digestive system, are also excluded. Additionally, patients who have experienced meningeal hemorrhage are not eligible.
Trial focus and goals: The main purpose of this study is to evaluate whether naloxegol can effectively prevent early constipation and ventilator-associated pneumonia (lung infections) in brain injury patients who are being treated with opioid pain medications. These complications are common in intensive care patients and can significantly impact recovery. Researchers will monitor whether participants have bowel movements and whether they develop lung infections during the first week of hospitalization. The study also tracks other important factors such as whether patients meet their nutritional goals, how long they need mechanical ventilation, their length of stay in the intensive care unit, and their overall recovery six months after joining the trial using a scale called the Glasgow Outcome Scale Extended.
Investigational drug: The medication being tested is naloxegol, marketed under the brand name Moventig. This medication works by blocking the effects of opioids specifically in the gut, which helps maintain normal bowel movements without interfering with pain relief in the brain. It is classified as a peripherally acting mu-opioid receptor antagonist. Participants will receive either Moventig 25 mg tablets or a placebo (an inactive substance that looks identical to the medication) taken orally. The study aims to determine if naloxegol can prevent the digestive complications commonly caused by opioid use in critically ill patients with brain injuries. The trial is expected to continue until September 2026.
Summary
Currently, research efforts for meningorrhagia are limited, with only one active clinical trial focusing on this condition. This trial is being conducted exclusively in France and represents an important investigation into managing complications in patients with brain injuries who require intensive care. Rather than treating the hemorrhage itself, the study focuses on preventing secondary complications that can arise during treatment, specifically constipation and lung infections caused by necessary pain medications. The trial highlights the challenge of balancing effective pain management with maintaining normal bodily functions in critically ill patients. The use of naloxegol represents a targeted approach to addressing opioid-related digestive complications without compromising pain relief, which is crucial for patients recovering from serious brain injuries.