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Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)

Study acronym: Proteomics
StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Trial status: Active, Not Recruiting to Completed

    Primary completion date changed from estimate of Dec 2030 to Oct 30, 2015; Study completion date changed from estimate of Dec 2030 to Jun 8, 2026; Start date: Jul 2004 to Aug 25, 2004

    Study Status, Arms and Interventionsv31

  2. Minor

    3 amendments

    3 re-verifications since 2023-08-28, no change to tracked fields

    v28-v30

  3. Notable

    Primary and study completion dates: Dec 2024 to Dec 2030

    Study Statusv27

  4. Minor

    Study Status, References

    v26

  5. Notable

    Primary and study completion dates: Dec 2021 to Dec 2024

    Study Status, Sponsor/Collaboratorsv25

Show 23 earlier versions

  1. Notable

    Primary completion date: Dec 2018 to Dec 2021

    Completion date: Dec 2020 to Dec 2021

    Study Statusv24

  2. Minor

    Study Status

    Re-verified, no change to tracked fields

    v23

  3. Notable

    Primary completion date: Apr 2018 to Dec 2018

    Study Statusv22

  4. Notable

    Primary completion date: Apr 2017 to Apr 2018

    Study Statusv21

  5. Minor

    Completion date: Dec 2017 to Dec 2020

    Study Identification, Study Status, Outcome Measures, Contacts/Locations, IPDSharingv20

  6. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Status, Contacts/Locationsv19

  7. Notable

    Primary completion date: Apr 2015 to Apr 2017

    Completion date: Dec 2015 to Dec 2017

    Study Status, Arms and Interventionsv18

  8. Notable

    Primary completion date: Apr 2014 to Apr 2015

    Completion date: Dec 2014 to Dec 2015

    Study Statusv17

  9. Minor

    Study Status

    Re-verified, no change to tracked fields

    v16

  10. Minor

    Primary completion date: Apr 2014

    Study Statusv15

  11. Minor

    Completion date: Dec 2011 to Dec 2014

    Interventions: blood/saliva samples will be collected for protein/molecular analysis (Other) to Blood/saliva samples for protein/molecular analysis (Other); Site contact updated

    Study Status, Sponsor/Collaborators, Arms and Interventions, Contacts/Locationsv14

  12. Minor

    Eligibility criteria expanded, about 1 word

    Show what changed: Eligibility criteria
    [...] gical or psychiatric disorders or alcohol or drug dependency. Exclusion Criteria: Inability to obtain informed consent

    Study Status, Arms and Interventions, Eligibilityv13

  13. Minor

    Completion date: Dec 2009 to Dec 2011

    Study Status, Contacts/Locationsv12

  14. Minor

    Study Identification, Study Status

    v11

  15. Minor

    Completion date: Jul 2009 to Dec 2009

    Study Statusv10

  16. Minor

    Study Status

    Re-verified, no change to tracked fields

    v9

  17. Minor

    Enrollment target: 180 to 260

    Interventions: blood samples will be collected for protein analysis (Other) to blood/saliva samples will be collected for protein/molecular analysis (Other); Eligibility criteria expanded, about 115 words; Site contact updated; and 1 more

    Show all 5 changes in this update
    • Minor Enrollment target: 180 to 260
    • Minor Interventions: blood samples will be collected for protein analysis (Other) to blood/saliva samples will be collected for protein/molecular analysis (Other)
    • Minor Eligibility criteria expanded, about 115 words
      Show what changed
      Inclusion Criteria: 14-65 years old Non-penetrating brain injury ICP monitor or Healthy volunteer or The orthopedic injury cohort will include patients admitted to the ED able to provide informed consent with the following: Fracture confirmed radiographically No head trauma No other known inflammatory process or infection No history of neurological or psychiatric disorders or alcohol or drug depend [...] Exclusion Criteria: Inability to obtain informed consent
    • Minor Site contact updated
    • Minor Study arms: 2 to 4

    Study Status, Study Design, Arms and Interventions, Eligibility, Contacts/Locationsv8

  18. Minor

    Completion date: Jul 2009

    Interventions: blood samples will be collected for protein analysis (Procedure) to blood samples will be collected for protein analysis (Other); Study arms: 0 to 2

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Eligibilityv7

  19. Minor

    Collaborators revised (2)

    Show what changed: Collaborators
    UTHSC-HThe Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston

    Study Status, Sponsor/Collaborators, Study Designv6

  20. Minor

    Eligibility criteria shortened, about 4 words

    Study description expanded, about 4 words; Collaborators: 1 to 2

    Show what changed: Eligibility criteria
    Inclusion Criteria: 1. 14-65 years old 2. Non-penetrating brain injury 3. ICP monitor or Healthy volunteer Exclusion Criteria: 1. Inability to obtain informed consent
    Show what changed: Study description
    [...] to elevations in ICP. We propose to employ mass spectrometry, antibody array and ELISA to profile proteins in the serum of patients suffering from [...]
    Show what changed: Collaborators
    UTHSC-H Clinical Research Unit

    Study Status, Sponsor/Collaborators, Study Description, Eligibility, Contacts/Locationsv5

  21. Minor

    Interventions: serum samples will be collected for protein analysis (Procedure) to blood samples will be collected for protein analysis (Procedure)

    Study description revised

    Show what changed: Study description
    [...] P. The specific aim of this research is to determine if the serumblood from brain-injured patients contains reproducible protein m [...]

    Study Status, Study Description, Arms and Interventionsv4

  22. Minor

    Collaborators: 2 to 1

    Show what changed: Collaborators
    National Center for Research Resources (NCRR)

    Study Status, Sponsor/Collaboratorsv3

  23. Minor

    Eligibility criteria shortened, about 10 words

    Show what changed: Eligibility criteria
    [...] Exclusion Criteria: 1. Inability to obtain informed consent 2. ICP>30 mmHg within the first 24 hours of injury

    Study Status, Eligibilityv2

  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.
The specific aim of this research is to determine if the blood from brain-injured patients contains reproducible protein markers that appear prior to elevations in intracranial pressure (ICP).
Trial Details
NCT Number NCT00178659
Lead Sponsor The University of Texas Health Science Center, Houston
Collaborators: TIRR/Mission Connect, The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
Conditions Brain Injuries, Traumatic, Traumatic Brain Injury
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov