NCT05889650

Brief Summary

The goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift \<5mm without increasing the risk of neurological worsening or cerebral herniation. All participants will receive routine usual care. The study group will additionally have ELD for cerebrospinal fluid (CSF) drainage. A comparison will be made between the usual treatment plus ELD (interventional) groups, and the usual treatment (control) groups on incidence rate of neurological worsening or cerebral herniation events, and whether total hours with raised intracranial pressure (ICP) are different.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
26mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jun 2024Jun 2028

First Submitted

Initial submission to the registry

May 20, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 24, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2028

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

May 20, 2023

Last Update Submit

April 20, 2026

Conditions

Severe Traumatic Brain InjuryIntracranial Hypertension

Keywords

Traumatic brain injuryintracranial pressureintracranial hypertensionlumbar drainage

Outcome Measures

Primary Outcomes (2)

  • Safety of ELD in selected Severe TBI patients

    Rate of occurrence of herniation events or death in 3 arms

    10 days

  • Feasibility of ELD in selected Severe TBI patients

    Proportion of patients able to undergo treatment as per randomised arm

    10 days

Secondary Outcomes (2)

  • Reduction in ICP burden using ELD in selected severe TBI patients

    10 days

  • Utility of automated pupillometry to predict safety of ELD

    10 days

Study Arms (3)

1st stage - prophylactic

EXPERIMENTAL

External lumbar drainage @15mmHg if intracranial pressure is not raised on admission

Procedure: External Lumbar drainage

2nd stage - treatment

EXPERIMENTAL

External lumbar drainage @20mmHg if / when intracranial pressure \>20mmHg and tier 1 therapies cannot achieve ICP\<20mmHg

Procedure: External Lumbar drainage

Usual treatment

NO INTERVENTION

Usual treatment as per SIBICC algorithm

Interventions

External Lumbar drainagePROCEDURE

ELD @ 15 or 20mmHg based on intervention arm with maximum of 10ml/hour drainage

1st stage - prophylactic2nd stage - treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years age
  • Glasgow Coma Scale (GCS) 3-8
  • Pupils symmetric and bilaterally reactive
  • Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT
  • Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT
  • First randomization and intervention may be commenced within 24 hours of injury
  • ELD safety score ≥5

You may not qualify if:

  • GCS \>8
  • Cisterns on CT completely effaced
  • Midline shift on CT \>5mm
  • GCS 3 with dilated and fixed pupils
  • Uncal or tonsillar herniation on admission or post-operative brain CT
  • Temporal lobe contusions with effaced ipsilateral cisterns
  • Penetrating TBI
  • Primary hemicraniectomy
  • Pregnancy
  • Prisoners
  • Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care
  • Pre-existing conditions affecting functional status or life expectancy to less than 1 year
  • Contra-indications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia \<50,000, or severe spinal deformity.
  • posterior fossa hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

RECRUITING

University of Houston Medical Center

Houston, Texas, 77030, United States

RECRUITING

University of Texas

San Antonio, Texas, 78249, United States

RECRUITING

Related Publications (8)

  • Badhiwala J, Lumba-Brown A, Hawryluk GWJ, Ghajar J. External Lumbar Drainage following Traumatic Intracranial Hypertension: A Systematic Review and Meta-Analysis. Neurosurgery. 2021 Aug 16;89(3):395-405. doi: 10.1093/neuros/nyab181.

    PMID: 34171100BACKGROUND

  • Ginalis EE, Fernandez LL, Avila JP, Aristizabal S, Rubiano AM. A review of external lumbar drainage for the management of intracranial hypertension in traumatic brain injury. Neurochirurgie. 2022 Feb;68(2):206-211. doi: 10.1016/j.neuchi.2021.05.004. Epub 2021 May 26.

    PMID: 34051245BACKGROUND

  • Bauer M, Sohm F, Thome C, Ortler M. Refractory intracranial hypertension in traumatic brain injury: Proposal for a novel score to assess the safety of lumbar cerebrospinal fluid drainage. Surg Neurol Int. 2017 Nov 1;8:265. doi: 10.4103/sni.sni_98_17. eCollection 2017.

    PMID: 29184716BACKGROUND

  • Llompart-Pou JA, Abadal JM, Perez-Barcena J, Molina M, Brell M, Ibanez J, Raurich JM, Ibanez J, Homar J. Long-term follow-up of patients with post-traumatic refractory high intracranial pressure treated with lumbar drainage. Anaesth Intensive Care. 2011 Jan;39(1):79-83. doi: 10.1177/0310057X1103900113.

    PMID: 21375095BACKGROUND

  • Murad A, Ghostine S, Colohan AR. A case for further investigating the use of controlled lumbar cerebrospinal fluid drainage for the control of intracranial pressure. World Neurosurg. 2012 Jan;77(1):160-5. doi: 10.1016/j.wneu.2011.06.018. Epub 2011 Nov 15.

    PMID: 22154151BACKGROUND

  • Abadal-Centellas JM, Llompart-Pou JA, Homar-Ramirez J, Perez-Barcena J, Rossello-Ferrer A, Ibanez-Juve J. Neurologic outcome of posttraumatic refractory intracranial hypertension treated with external lumbar drainage. J Trauma. 2007 Feb;62(2):282-6; discussion 286. doi: 10.1097/01.ta.0000199422.01949.78.

    PMID: 17297313BACKGROUND

  • 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: 19249925BACKGROUND

  • Hawryluk GWJ, Aguilera S, Buki A, Bulger E, Citerio G, Cooper DJ, Arrastia RD, Diringer M, Figaji A, Gao G, Geocadin R, Ghajar J, Harris O, Hoffer A, Hutchinson P, Joseph M, Kitagawa R, Manley G, Mayer S, Menon DK, Meyfroidt G, Michael DB, Oddo M, Okonkwo D, Patel M, Robertson C, Rosenfeld JV, Rubiano AM, Sahuquillo J, Servadei F, Shutter L, Stein D, Stocchetti N, Taccone FS, Timmons S, Tsai E, Ullman JS, Vespa P, Videtta W, Wright DW, Zammit C, Chesnut RM. A management algorithm for patients with intracranial pressure monitoring: the Seattle International Severe Traumatic Brain Injury Consensus Conference (SIBICC). Intensive Care Med. 2019 Dec;45(12):1783-1794. doi: 10.1007/s00134-019-05805-9. Epub 2019 Oct 28.

    PMID: 31659383BACKGROUND

MeSH Terms

Conditions

Brain Injuries, TraumaticIntracranial Hypertension

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Halinder S Mangat, MD MSc

    Brain Trauma Foundation; Kansas University Medical Center Research Institute

    PRINCIPAL INVESTIGATOR

  • Jamshid Ghajar, MD PhD

    Brain Trauma Foundation

    PRINCIPAL INVESTIGATOR

  • Gregory Hawryluk, MD PhD

    Cleveland Clinic Foundation, Brain Trauma Foundation

    PRINCIPAL INVESTIGATOR

  • Bradley Dengler, MD

    Military Traumatic Brain Injury Initiative, Uniformed Services University

    STUDY CHAIR

Central Study Contacts

Carlos Morales, MPH

CONTACT

240-6536638carlos.morales.ctr@usuhs.edu

Halinder S Mangat, MD, MSc

CONTACT

913-5886970elastic@braintrauma.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Unaware of randomisation arm
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 2-stage randomization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

May 20, 2023

First Posted

June 5, 2023

Study Start

June 24, 2024

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(6)