EARLYdrain - Outcome After Early Lumbar CSF-drainage in Aneurysmal SAH

NCT01258257 | Completed Phase 3 DMC

• 1 other identifier: EARLYDRAIN
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The intention of the study is to investigate whether drainage of cerebral spinal fluid via a lumbar route ("Tuohy-drain") will improve outcome after intracranial aneurysmal subarachnoid hemorrhage (SAH).

Conditions

Aneurysmal Subarachnoid Hemorrhage

Keywords

Aneurysm; Subarachnoid hemorrhage; Lumbar drain; Cerebral vasospasm; Cerebral Ventricles; Cerebrospinal Fluid; Prospective Studies; Drainage/methods*; Humans; Subarachnoid Hemorrhage/cerebrospinal fluid*; Subarachnoid Hemorrhage/complications*; Subarachnoid Space/surgery*; Vasospasm, Intracranial/etiology; Vasospasm, Intracranial/surgery*

Outcome Measures

Primary Outcomes (1)

• Disability in Lumbar drainage group (LD) vs. disability in control group (No-LD)

  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)).

  6 months after SAH

Secondary Outcomes (9)

• mortality

  6 months after SAH

• Modified Rankin scale (mRS) score as continuous variable

  6 months after SAH

• Angiographically determined vasospasm

  once between day 7 to 9 after SAH

• Vasospastic infarction

  last CT-scan during hospital stay, an expected average of 4 weeks

• Expression of clinical delayed neurological deficit

  day 1-14 after SAH

Study Arms (2)

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.

Procedure: Insertion of a lumbar drain

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.

Interventions

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.

Also known as: Tuohy drain

Lumbar drain (LD) / Tuohy drain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 capable of giving informed consent nor a legal representative is available, informed consent can be given by an independent physician neither involved in the patient´s treatment nor the trial (for specification see below)

You may not qualify if:

• Subarachnoid hemorrhage of other than aneurysmal origin
• No hemorrhage visible on initial CCT scan (Fisher Grade I)
• Pregnancy
• Concurrent participation in another interventional trial (participation in an observational trial is allowed)
• Life expectancy less than 1 year for other reasons than the actual SAH
• Other concomitant severe disease that would confound with treatment
• Other clear contraindication for treatment

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité University Medicine Department of Neurosurgery Campus Virchow Klinikum

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (7)

• Klimo P Jr, Kestle JR, MacDonald JD, Schmidt RH. Marked reduction of cerebral vasospasm with lumbar drainage of cerebrospinal fluid after subarachnoid hemorrhage. J Neurosurg. 2004 Feb;100(2):215-24. doi: 10.3171/jns.2004.100.2.0215.

  PMID: 15086227 BACKGROUND

• Kwon OY, Kim YJ, Kim YJ, Cho CS, Lee SK, Cho MK. The Utility and Benefits of External Lumbar CSF Drainage after Endovascular Coiling on Aneurysmal Subarachnoid Hemorrhage. J Korean Neurosurg Soc. 2008 Jun;43(6):281-7. doi: 10.3340/jkns.2008.43.6.281. Epub 2008 Jun 20.

  PMID: 19096633 BACKGROUND

• Tuettenberg J, Czabanka M, Horn P, Woitzik J, Barth M, Thome C, Vajkoczy P, Schmiedek P, Muench E. Clinical evaluation of the safety and efficacy of lumbar cerebrospinal fluid drainage for the treatment of refractory increased intracranial pressure. J Neurosurg. 2009 Jun;110(6):1200-8. doi: 10.3171/2008.10.JNS08293.

  PMID: 19249925 BACKGROUND

• Truckenmueller P, Wolf S, Wasilewski D, Vajkoczy P, Fruh A; Earlydrain Study Group. Association of Fluid Balance and Hemoglobin Decline With Neurological Outcome After Aneurysmal Subarachnoid Hemorrhage. Crit Care Med. 2024 Sep 1;52(9):1391-1401. doi: 10.1097/CCM.0000000000006332. Epub 2024 May 21.

  PMID: 38775857 DERIVED

• Fruh A, Truckenmuller P, Wasilewski D, Vajkoczy P, Wolf S; Earlydrain Study Group. Analysis of Cerebral Spinal Fluid Drainage and Intracranial Pressure Peaks in Patients with Subarachnoid Hemorrhage. Neurocrit Care. 2024 Oct;41(2):619-631. doi: 10.1007/s12028-024-01981-9. Epub 2024 Apr 15.

  PMID: 38622488 DERIVED

• Wolf S, Mielke D, Barner C, Malinova V, Kerz T, Wostrack M, Czorlich P, Salih F, Engel DC, Ehlert A, Staykov D, Alturki AY, Sure U, Bardutzky J, Schroeder HWS, Schurer L, Beck J, Juratli TA, Fritsch M, Lemcke J, Pohrt A, Meyer B, Schwab S, Rohde V, Vajkoczy P; EARLYDRAIN Study Group. Effectiveness of Lumbar Cerebrospinal Fluid Drain Among Patients With Aneurysmal Subarachnoid Hemorrhage: A Randomized Clinical Trial. JAMA Neurol. 2023 Aug 1;80(8):833-842. doi: 10.1001/jamaneurol.2023.1792.

  PMID: 37330974 DERIVED

• Bardutzky J, Witsch J, Juttler E, Schwab S, Vajkoczy P, Wolf S. EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial. Trials. 2011 Sep 14;12:203. doi: 10.1186/1745-6215-12-203.

  PMID: 21917146 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Aneurysm; Vasospasm, Intracranial

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Wolf, Dr.

  Charite University medicine / department of neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stefan Wolf, MD

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)