NCT06911736 Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence
| NCT ID | NCT06911736 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad de Antioquia |
| Condition | Chronic Subdural Hematoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 254 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 254 participants in total. It began in 2024-06-01 with a primary completion date of 2025-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery. Materials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).
Eligibility Criteria
Inclusion Criteria: * The study included patients aged 18 years or older who required surgical management of symptomatic CSH confirmed by CT scan and whose informed consent was given by the patient or responsible family member to participate in the study Exclusion Criteria: * Pregnant or breastfeeding * Conditions in which the trendelenburg position might not be safe, such as intracranial hypertension without a drain to allow evacuation of the hematoma, cardiovascular instability (severe heart failure, unstable angina, cardiogenic pulmonary edema), acute respiratory distress syndrome without a secure airway, glaucoma, spinal cord trauma not stabilized with surgery, peripheral vascular disease, * History of ipsilateral chronic subdural hematoma drainage, intracranial hypotension syndrome, ventriculoperitoneal shunting * Simultaneous participation in any other clinical trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06911736 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Subdural Hematoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06911736 currently recruiting?
Yes, NCT06911736 is actively recruiting participants. Contact the research team at montenegromjh@gmail.com for enrollment information.
Where is the NCT06911736 trial being conducted?
This trial is being conducted at Medellín, Colombia, Medellín, Colombia, Medellín, Colombia.
Who is sponsoring the NCT06911736 clinical trial?
NCT06911736 is sponsored by Universidad de Antioquia. The trial plans to enroll 254 participants.