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NCT05889650: ELASTIC
External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial
NA trial testing External Lumbar drainage in Severe Traumatic Brain Injury in 30 participants. Currently enrolling.
15 June 2027
Quick facts
| Lead sponsor | Brain Trauma Foundation |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 24 June 2024 |
| Primary completion | 15 June 2027 |
| Estimated completion | 30 June 2027 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- External Lumbar drainage
Conditions studied
- Severe Traumatic Brain Injury — all drugs for Severe Traumatic Brain Injury →
- Intracranial Hypertension — all drugs for Intracranial Hypertension →
Sponsor
Brain Trauma Foundation
Who can join
Adults 18 to 65, any sex, with Severe Traumatic Brain Injury or Intracranial Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension Phase 1 Randomized Clinical Trial: Scientific Rationale and Methodology: An MTBI<sup>2</sup> Study.
Mangat HS, Hawryluk G, Gerber LM, Bokova E, et al · · 2025 · PMID 41163742 · DOI 10.1227/neuprac.0000000000000176
Verify or expand the search:
- PubMed search for NCT05889650
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Severe Traumatic Brain Injury
Currently open trials in the same condition.
- NCT06560372 — Incidence, Characteristics and Evolution of Cerebral Vasospasm With Clinical Impact in Moderate to Severe Traumatic Brai · NA · recruiting
- NCT05566431 — Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05889650 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Brain Trauma Foundation
- Last refreshed: 19 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05889650.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing