GET-UP Trial: Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas

Centro Hospitalar do Porto

Status: Unknown

Conditions: Chronic Subdural Hematoma

Treatments: Procedure: Early mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT03788005

2018-176 (151-DEFI/150-CES)

Details and patient eligibility

About

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.

Full description

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:

• Control group: bed rest 48 hours post-surgery with removal of subdural drains after this period.
• Intervention group: Early mobilization protocol: as early mobilization as possible, within a maximum of 12 hours following surgery, with progressive autonomization in the ward as tolerated by the patient. Mobilization time will be recorded. At the time of assuming an upright position the drains will be closed and will only be open again when the patient is in supine position (8 hours per day of supine position). Subdural drains will be removed after 48 hours, similar to the practice in the control group.

Primary End-Point:

• Number of medical complications. Medical complication is defined as any occurrence which merits additional tests or, preferentially, requires any form of medical treatment. This includes respiratory infections, urinary infections, wound infections, meningitis, deep vein thrombosis, pulmonary embolism, cerebral infarction or hemorrhage, syncope, among others.

Secondary End-Points:

• Recurrence rates. A recurrence is defined as any chronic subdural hematoma ipsilateral to that of the original hematoma if a surgical strategy needs to be pursued.
• Functional status (using both GOS-E and mRS). Timeframes considered will be pre-operative functional status, functional status at discharge, functional status at 3 months post-operative.
• Mortality rates.
• Recurrence free survival.
• Time to discharge.

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Surgically drained chronic subdural hematomas (Burr hole craniostomy)
• > or equal to 18 years old

Exclusion criteria

• Previous neurosurgery
• Surgery for another pathology performed at the same time
• > 6h sedation post-surgery
• Any previous condition that makes early mobilization impossible

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

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.

Treatment:

Procedure: Early mobilization

Control Group

No Intervention group

Description:

Bed rest with head of bed at 0 degrees for 48h. Subdural drains will be removed past 48 hours of surgery.