Preventing prolonged immobilisation due to presence of a subdural drain after evacuation of chronic subdural hematoma Surgery
Conditions
Interventions
Current interventions as of 13/10/2021:
The DRAIN TIME 2 study is a Danish, national, multicenter, randomized controlled non-inferiority trial with three parallel arms. The arms correspond to 6, 12, a
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients (aged =18 years) 2. Minimum 2 weeks since known head trauma 3. Patients with symptomatic CSDH confirmed on CT or magnetic resonance imaging (MRI), admitted to a neurosurgical department for operative treatment 4. Patients undergoing a single burr-hole evacuation and placement of a passive subdural drain
Exclusion criteria
Exclusion criteria: 1. Patients with abnormalities in their cerebrospinal fluid 2. Patients with changes or abnormalities in their normal cerebrospinal fluid dynamics, e.g. ventricular peritoneal shunt 3. Patients with additional intracranial pathology that requires neurosurgical treatment 4. Patients with recurrent CSDH or with previous craniotomy or other transcranial surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 13/10/2021: Recurrence rate at 90 days measured using modified Rankin Scale (mRS) at 90 days followup Previous primary outcome measure: At 3 months post-operatively. 1. Recurrence rate measured using mRS | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 13/10/2021: 1. Mortality rate at 90 days measured using patient records at 90 days follow-up 2. Disability measured using the modified Rankin Scale (mRS) at 90 days follow-up 3. Patient-reported health status of patients measured using The Short Form (36) Health Survey during admission and at 90 days follow-up 4. Number of hours post-surgery before the patients are mobilized out of bed measured using patient records during admission 5. Length of hospital stay measured as the length of patient stay at the department of neurosurgery before being discharged to home or transferred to another hospital using patient records during admission 6. Drain-related complications such as bleeding, pain, general discomfort, and infection measured by observation by a physician after removal of the drain 7. Complications related to immobilization such as back pain, deep venous thrombosis and/or pulmonary embolism, and constipation measured using patient records at 90 days follow-up Sub-analyses of patients with recurrence at 90 days follow-up: 1. Co-morbidities, medications, age, gender, and evaluation of hematoma subtypes on CT from admission (homogenous, separated, mixed, or membranous) will be collected using patient records at 90 days follow-up Previous secondary outcome measures: 1. Number of patients who have died at 3 months measured using patient records 2. Disability measured using the Modified Rankin Scale at 3 months 3. Health status of patients measured using The Short Form (36) Health Survey (during admission and again after 3 months) 4. Number of hours post-surgery before the patients are mobilized out of bed measured using patient records 5. Length of hospital stay (stay at department of neurosurgery before discharged to home of transferred to another hospital) measured using patient records 6. Drain-related complications such as bleeding, pain, general discomfort, infection measured by observation by a physician just after | — |
Countries
Denmark
Outcome results
None listed