Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Insertion of a lumbar drain · 1 trial · 1 indication
Disability is assessed by the modified Rankin Scale, dichotomized at a score of 0 to 2 versus 3 to 6 (6=death).Assessment is performed by a blinded investigator of the local study center by personal visit. Alternatively, a telephone questionnaire is suitable for outcome assessment of the modified Rankin Scale (13). Outcome assessment is planned to be done on the whole dataset as well as in preplanned stratified subsets (i.e. for example clinical SAH grade according to the Hunt\&Hess scale 1-2 vs. 3-5 (14), CT grading according to Fisher I-III vs. IV (15)).
| Arm | Type | Description |
|---|---|---|
| Lumbar drain (LD) / Tuohy drain | ACTIVE_COMPARATOR | Intervention: Insertion of a lumbar drain All patients in the LD group receives a lumbar drain during anesthesia required for aneurysm treatment. Drainage of CSF is started after the post-procedural CT scan on day one after aneurysm securement. |
| No Lumbar drain (NoLD) | NO_INTERVENTION | Patients randomized to the control group should not receive a lumbar drain before the planned control angiography to be performed on day 7 to 10 after SAH. If the patient develops hydrocephalus, and no EVD was placed initially for CSF drainage, a lumbar drain may be installed at the discretion of the local investigator. These patients are analyzed in the intention-to-treat analysis, but are not suitable for per-protocol analysis. |
| Name | Type | Description |
|---|---|---|
| Insertion of a lumbar drain | PROCEDURE | In patients in the LD group, after insertion of the drain CSF is drained slowly and steadily at a rate of approximately 5 ml per hour. This leads to a planned daily CSF drainage of about 120 ml per day via lumbar route. To facilitate accuracy of drainage, regular drainage control every other hour and stopping in case of unwarranted excess drainage is strongly recommended by the principal investigators. In case of neurological decline suspiciously related to the lumbar drainage, the drain is closed immediately and may be gradually restarted after 12 to 24 hours, after performing a CCT scan. The drain is planned to remain in place until the control angiography on day 7 to 10 after the initial hemorrhage. |
Inclusion Criteria: * Age of 18 years or older * First aneurysmal SAH * Pre-morbid modified Rankin Scale score 0 or 1 * Aneurysm treatment performed in the first 48 hours after the initial hemorrhage. * Informed consent by the patient or his/her legal representative. In case neither the patient is ...