Clinical trial NCT06510842: Lumbar Drainage of Intraventricular Hemorrhage
Official title: Lumbar Drainage of Intraventricular Hemorrhage the DRAIN IVH Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraventricular Hemorrhage
Lumbar Drainage
External Ventricular Drainage
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intracerebral hemorrhage (ICH) is a debilitating and fatal disease, especially when the hemorrhage is also entering the cerebral ventricles leading to acute hydrocephalus. In these cases, patients need a drainage through external ventricular drains (EVD). In the longer term, patients often need a permanent ventriculoperitoneal (VP) shunt to avoid hydrocephalus. Here we hypothesize that the early insertion of a lumbar drainage in addition to the EVD could lead to better functional outcome and avoidance of VP shunting by drainage of the blood which promotes inflammatory and adverse effects in the subarachnoid space. For that we propose a multi-center randomized clinical trial to investigate the hypothesis.


Eligibility criteria: Inclusion Criteria:

* ICH with IVH (with hemorrhage in the 3rd and/or 4rth ventricle) with the need for EVD placement due to acute hydrocephalus
* Age ≥ 18 y
* Lumbar drain can be inserted within 72 h after symptom onset or patient last seen well

Exclusion Criteria:

* Premorbid mRS score \> 2
* Pregnancy
* Life expectancy \<6 months
* Patient/family/caregiver unwilling or unlikely to opt for at least two weeks of aggressive therapy prior to consideration of transition to comfort measures/discontinuation of life support measures.
* Treating physicians deeming the prognosis as so grave that an aggressive therapy is not warranted.
* Other clear contraindication for treatment with a lumbar drain

Primary outcomes:
measure: Rate of mRS
timeFrame: 180 days (+/- 14 days)
Secondary outcomes:
measure: Amount of CSF drained by external ventricular drain
timeFrame: up to 14 days (duration of hospital stay)
measure: Amount of CSF drained by lumbar drain
timeFrame: up to 14 days (duration of hospital stay)
measure: Need for VP shunt
timeFrame: up to 14 days (duration of hospital stay)
measure: Need for VP shunt
timeFrame: at 180 days
measure: Clearance of intraventricular blood (via neuroimaging with CT or MRI)
timeFrame: up to 14 days (duration of hospital stay)
measure: Clearance of intraventricular blood (via neuroimaging with CT or MRI)
timeFrame: up to 14 days (duration of hospital stay)
measure: Bacterial Ventriculitis/Meningitis leading to antibiotic treatment
timeFrame: up to 14 days (duration of hospital stay)
measure: Mortality
timeFrame: up to 14 days (duration of hospital stay) and 6 month
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Neurology, University Hospital Heidelberg
state: Baden-Württemberg
city: München
country: Germany
facility: LMU München
state: Bayern
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin
Study officials:
affiliation: Heidelberg University Hospital, Department of Neurology
name: Silvia Schönenberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Staykov D, Kuramatsu JB, Bardutzky J, Volbers B, Gerner ST, Kloska SP, Doerfler A, Schwab S, Huttner HB. Efficacy and safety of combined intraventricular fibrinolysis with lumbar drainage for prevention of permanent shunt dependency after intracerebral hemorrhage with severe ventricular involvement: A randomized trial and individual patient data meta-analysis. Ann Neurol. 2017 Jan;81(1):93-103. doi: 10.1002/ana.24834.
citation: Staykov D, Huttner HB, Struffert T, Ganslandt O, Doerfler A, Schwab S, Bardutzky J. Intraventricular fibrinolysis and lumbar drainage for ventricular hemorrhage. Stroke. 2009 Oct;40(10):3275-80. doi: 10.1161/STROKEAHA.109.551945. Epub 2009 Aug 13.
citation: Kuramatsu JB, Gerner ST, Ziai W, Bardutzky J, Sembill JA, Sprugel MI, Mrochen A, Kolbl K, Ram M, Avadhani R, Falcone GJ, Selim MH, Lioutas VA, Endres M, Zweynert S, Vajkoczy P, Ringleb PA, Purrucker JC, Volkmann J, Neugebauer H, Erbguth F, Schellinger PD, Knappe UJ, Fink GR, Dohmen C, Minnerup J, Reichmann H, Schneider H, Rother J, Reimann G, Schwarz M, Bazner H, Classen J, Michalski D, Witte OW, Gunther A, Hamann GF, Lucking H, Dorfler A, Ishfaq MF, Chang JJ, Testai FD, Woo D, Alexandrov AV, Staykov D, Goyal N, Tsivgoulis G, Sheth KN, Awad IA, Schwab S, Hanley DF, Huttner HB; Collaborators. Association of Intraventricular Fibrinolysis With Clinical Outcomes in Intracerebral Hemorrhage: An Individual Participant Data Meta-Analysis. Stroke. 2022 Sep;53(9):2876-2886. doi: 10.1161/STROKEAHA.121.038455. Epub 2022 May 6.