Effectiveness of Lumbar Cerebrospinal Fluid Drain Among Patients With Aneurysmal Subarachnoid Hemorrhage
Authors: Wolf Stefan , Mielke Dorothee , Barner Christoph , Malinova Vesna , Kerz Thomas , Wostrack Maria , Czorlich Patrick , Salih Farid , Engel Doortje C. , Ehlert Angelika , Staykov Dimitre , Alturki Abdulrahman Y. , Sure Ulrich , Bardutzky Jürgen , Schroeder Henry W. S. , Schürer Ludwig , Beck Jürgen , Juratli Tareq A. , Fritsch Michael , Lemcke Johannes , Pohrt Anne , Meyer Bernhard , Schwab Stefan , Rohde Veit , Vajkoczy Peter ,   EARLYDRAIN Study Group, Baro Norbert , Bauer Miriam , Dengler Nora F. , von Dincklage Falk , Finger Tobias , Francis Roland , Hotter Benjamin , Hunsicker Oliver , Jussen Daniel , Jüttler Eric , Schaumann Andreas , Witsch Jens , Nagel Christoph , Meier Ullrich , Podlesik Dino , Schackert Gabriele , Huttner Hagen , Hagedorn Sabine , Müller Daniela , Müller Oliver , Sarge Robert , Niesen Wolf-Dirk , Lange Katharina , Päsler Dennis , Reinhardt Stephanie , Regelsberger Jan , Sauvigny Thomas , Westphal Manfred , Gremmer Rudolf , Beyer Christian , Beyer Desiree , Huthmann Alexandra , Landscheidt Julia , Schul David B. , Ryang Yu-Mi , Toeroek Elisabeth , Arouk Wasim , Al-Jehani Hosam , Sinclair David B. , Fung Christian , Soell Nicole , Hildebrandt Gerhard , Huscher Karen , Lange Heidrun , Hutchinson Peter , Tseng Ming-Yuan 
Published: June 2023

Importance

After aneurysmal subarachnoid hemorrhage, the use of lumbar drains has been suggested to decrease the incidence of delayed cerebral ischemia and improve long-term outcome.

Objective

To determine the effectiveness of early lumbar cerebrospinal fluid drainage added to standard of care in patients after aneurysmal subarachnoid hemorrhage.

Design, Setting, and Participants

The EARLYDRAIN trial was a pragmatic, multicenter, parallel-group, open-label randomized clinical trial with blinded end point evaluation conducted at 19 centers in Germany, Switzerland, and Canada. The first patient entered January 31, 2011, and the last on January 24, 2016, after 307 randomizations. Follow-up was completed July 2016. Query and retrieval of data on missing items in the case report forms was completed in September 2020. A total of 20 randomizations were invalid, the main reason being lack of informed consent. No participants meeting all inclusion and exclusion criteria were excluded from the intention-to-treat analysis. Exclusion of patients was only performed in per-protocol sensitivity analysis. A total of 287 adult patients with acute aneurysmal subarachnoid hemorrhage of all clinical grades were analyzable. Aneurysm treatment with clipping or coiling was performed within 48 hours.

Intervention

A total of 144 patients were randomized to receive an additional lumbar drain after aneurysm treatment and 143 patients to standard of care only. Early lumbar drainage with 5 mL per hour was started within 72 hours of the subarachnoid hemorrhage.

Main Outcomes and Measures

Primary outcome was the rate of unfavorable outcome, defined as modified Rankin Scale score of 3 to 6 (range, 0 to 6), obtained by masked assessors 6 months after hemorrhage.

Results

Of 287 included patients, 197 (68.6%) were female, and the median (IQR) age was 55 (48-63) years. Lumbar drainage started at a median (IQR) of day 2 (1-2) after aneurysmal subarachnoid hemorrhage. At 6 months, 47 patients (32.6%) in the lumbar drain group and 64 patients (44.8%) in the standard of care group had an unfavorable neurological outcome (risk ratio, 0.73; 95% CI, 0.52 to 0.98; absolute risk difference, −0.12; 95% CI, −0.23 to −0.01; P = .04). Patients treated with a lumbar drain had fewer secondary infarctions at discharge (41 patients [28.5%] vs 57 patients [39.9%]; risk ratio, 0.71; 95% CI, 0.49 to 0.99; absolute risk difference, −0.11; 95% CI, −0.22 to 0; P = .04).

Conclusion and Relevance

In this trial, prophylactic lumbar drainage after aneurysmal subarachnoid hemorrhage lessened the burden of secondary infarction and decreased the rate of unfavorable outcome at 6 months. These findings support the use of lumbar drains after aneurysmal subarachnoid hemorrhage.

Trial Registration

ClinicalTrials.gov Identifier: NCT01258257