Head injury Trials in Disease

Study on Naloxegol to Prevent Constipation in Patients with Brain Injury and Opioid Use

This clinical trial is investigating the use of naloxegol (brand name Moventig) in patients who have suffered from head trauma or a specific type of bleeding in the brain called subarachnoid hemorrhage. These conditions often require treatment with strong pain medications known as opioids, which can cause digestive problems, particularly constipation. The study aims to determine whether naloxegol can help prevent both early constipation and lung infections in these critically ill patients while they are in intensive care.

Main inclusion criteria:

• Patients must be 18 years of age or older
• Admission to the intensive care unit due to head trauma or subarachnoid hemorrhage without other life-threatening injuries
• Receiving sedation for brain protection using specific opioid medications (such as Sufentanil, Fentanyl, Remifentanil, or Morphine) given through a vein for less than 24 hours
• Expected to need mechanical ventilation (breathing machine) and sedation for at least 48 hours
• Requiring monitoring of intracranial pressure (pressure inside the skull)
• Planned to receive enteral feeding (nutrition through a tube into the stomach)
• Must be affiliated with or benefiting from a social security scheme

Main exclusion criteria:

• Patients with a previous history of head trauma
• Patients with pre-existing gastrointestinal motility disorders (problems with the normal movement of food through the digestive system)
• Patients who have experienced meningeal hemorrhage (bleeding in the protective layers covering the brain and spinal cord) in the past

Focus and goal of the trial:

The primary goal is to evaluate how effective naloxegol is in preventing early constipation and ventilator-associated pneumonia (lung infections that can occur when patients are on breathing machines) during the first week of hospitalization. The study will monitor whether patients have bowel movements and whether they develop pneumonia during this critical period.

Secondary assessments include evaluating nutritional intake, the need for additional medications to manage vomiting or constipation, the duration of mechanical ventilation, the length of stay in the intensive care unit, and the patient's recovery status six months after joining the trial. Recovery will be measured using the Glasgow Outcome Scale Extended, which is a standard tool for measuring recovery after brain injury.

Investigational drug:

The medication being tested is naloxegol, which is given as a 25 mg oral tablet. Naloxegol works by blocking the effects of opioid pain medications on the gut while not interfering with pain relief in the brain. This helps maintain normal bowel movements in patients who are receiving opioids for pain management. In this study, participants will receive either the active medication or a placebo (an inactive substance that looks like the medication). The trial is expected to conclude by September 2026.