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PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)

Study acronym: PROTEST
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Site details revised at 12 of 12 sites
    • Collaborators: 2 to 1
    v11
  2. Minor Re-verified, no change to tracked fieldsv10
  3. Notable Primary completion date: Dec 2022 to Dec 2026
    • Study sites: 10 to 12
    • Study completion date: Dec 2023 to Dec 2027
    • Eligibility criteria expanded, about 30 words
    v9
  4. Minor Eligibility criteria expanded, about 80 words
    • Site contacts updated at 1 of 10 sites
    v8
  5. Minor Site details revised at 5 of 10 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv6
  2. Minor Site details revised at 5 of 10 sitesv5
  3. Minor Study sites: 1 to 10v4
  4. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Enrollment target: 1500 to 1100
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2018 to Jul 19, 2018
    • Eligibility criteria shortened, about 25 words
    • Secondary endpoints: details revised at 1 of 10 entries
  5. Notable Start date: Jun 2018 to Sep 2018v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a phase III, multi-centre, double blind, randomized controlled trial of patients with traumatic brain injury (TBI).
Trial Details
NCT Number NCT03559114
Lead Sponsor Sunnybrook Health Sciences Centre
Collaborators: Sunnybrook Research Institute
Conditions
(from sponsor)
Traumatic Brain Injury
Related terms Brain Injuries, Traumatic, Venous Thrombosis
Enrollment 1,100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov