An interventional study of Early mobilization in Chronic Subdural Hematoma, sponsored by Centro Hospitalar do Porto. Status unknown at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by Centro Hospitalar do Porto · Not applicable, Interventional, and Treatment
Compare rates of medical complications, recurrence and outcome in 2 randomized groups of patients with surgical chronic subdural hematomas. The intervention group will be assigned to early mobilization (within 12 hours of the surgical procedure). The control group will be assigned to bed rest for 48 hours.
At Centro Hospitalar do Porto it is routinely used burr hole craniostomy with subdural drains and 48 hours of bed rest for the surgical treatment of chronic subdural hematomas. After 48 hours the subdural drains are removed and the patient is allowed to mobilize for the first time.
The aim of the present study is to conduct a prospective, randomized, controlled trial with an early mobilization protocol vs 48 hours bed rest to determine the best strategy to reduce postoperative complications and improve functional outcomes.
There will be 2 groups:
Primary End-Point:
Secondary End-Points:
Exclusion Criteria:
Early mobilization as soon as possible, within a maximum of 12 hours post-surgery. Subdural drains will be closed when the patient is allowed to mobilize and will be open during a nocturnal period of 8 hours. Subdural drains will be removed past 48 hours of surgery.
Procedure: Early mobilization
Bed rest with head of bed at 0 degrees for 48h. Subdural drains will be removed past 48 hours of surgery.
Early mobilization as soon as possible and within a maximum of 12 hours following burr hole craniostomy for chronic subdural hematomas.
Medical Complications
Infections, venous thromboembolism, seizures
Time frame: From date of randomization until 3 months post-randomization
Recurrence
Recurrence of a chronic subdural hematoma if surgical intervention is required
Time frame: At 3 months follow-up
Post-operative Modified Rankin scale
Modified Rankin Scale from 0 (free of symptoms) to a maximum of 6 (dead)
Time frame: At 3 months follow-up
Survival
Survival
Time frame: At 3 months follow-up
Length of hospital stay
Time to clinical discharge
Time frame: From date of randomization until clinical discharge up to 36 months
Post-operative GOS-E scale
GOS-E scale from 1 (dead) to a maximum of 8 (upper good recovery - resumption of normal life within the capacity work even if pre-injury status has not been achieved; any existing deficits are not disabling)
Time frame: At 3 months follow-up
Plan to share: Undecided
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Centro Hospitalar do Porto