Investigating early mobilization effects in patients with aneurysmal subarachnoid hemorrhage
The Investigation of the Impact of Early Mobilization on the Outcome, the Appearance of Early Ischemic Damage, the Functional Status, and the Length of Intensive Care Treatment in Patients With Aneurysmal Subarachnoid Hemorrhage.
This study is testing if getting patients moving sooner after a brain bleed from an aneurysm helps them recover better than just resting in bed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Pecs Academic / other |
| Locations | 3 sites (Pécs, Baranya and 2 other locations) |
| Trial ID | NCT06436508 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of early mobilization compared to standard bed rest care on the outcomes of patients who have experienced a subarachnoid hemorrhage due to an aneurysm rupture. Participants will be randomly assigned to receive either an early mobilization protocol or standard care following aneurysm occlusion. The study will assess both primary and secondary outcomes to determine the effectiveness of early mobilization in improving recovery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a modified Rankin Scale score of 0-2 and who have undergone aneurysm occlusion.
Not a fit: Patients under 18 years old, those with traumatic subarachnoid hemorrhage, or those with multiple untreated aneurysms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes for patients with aneurysmal subarachnoid hemorrhage.
How similar studies have performed: Other studies have shown promising results with early mobilization approaches in similar patient populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 ys * Premorbid modified Rankin Scale score of 0-2 * WFNS I-IV at enrollment * Aneurysm occlusion has occurred through open or endovascular means * Minimum 24 hours elapsed after aneurysm occlusion * The patient has not received thrombolytic therapy * Vital parameters are appropriate (mean arterial pressure \[MAP\] \>80 or \>110 mm Hg) * Signed patient information and consent form * Enrollment occurs within 72 hours following ictus Exclusion Criteria: * Age under 18 years * Traumatic subarachnoid hemorrhage * Incapacitated or limited capacity for action before ictus * Confirmed pregnancy * Aneurysm multiplicity (unless all aneurysms are treated)
Where this trial is running
Pécs, Baranya and 2 other locations
- University of Pecs — Pécs, Baranya, Hungary (Recruiting)
- Central Hospital of B.A.Z. County — Miskolc, Baz, Hungary (Recruiting)
- National Institute of Mental Health, Neurology, and Neurosurgery — Budapest, Hungary (Recruiting)
Study contacts
- Principal investigator: Peter Csecsei, MD. PhD — University of Pecs
- Study coordinator: Peter Csecsei, MD. PhD
- Email: csecsei.peter@pte.hu
- Phone: +0672535900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.