NCT00048646

Brief Summary

The purpose of this study is to determine if progesterone treatment safely reduces brain swelling and damage after injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2002

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 1, 2002

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

3.3 years

First QC Date

November 4, 2002

Last Update Submit

September 17, 2014

Conditions

Traumatic Brain Injury

Keywords

TBIProTECT

Outcome Measures

Primary Outcomes (1)

  • neurological outcome

    GOS, DRS, and GOAT

    30 days

Study Arms (2)

placebo

PLACEBO COMPARATOR

placebo

Drug: IV Progesterone

IV progesterone

EXPERIMENTAL

IV progesterone

Drug: IV Progesterone

Interventions

IV ProgesteroneDRUG
IV progesteroneplacebo

Eligibility Criteria

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

You may qualify if:

  • Blunt head trauma occuring within 11 hours
  • Ages 18 years and older (or Tanner Score of 5)
  • Index GCS between 4 and 12

You may not qualify if:

  • Spinal cord injury
  • Penetrating head trauma
  • Cardiopulmonary arrest upon ECC arrival
  • Status Epilepticus upon ECC arrival
  • Systolic BP \< 90mmHG upon ECC arrival
  • Pulse Ox of \< 90 (or pO2 \< 60)
  • Prisoners or incarcerated individuals
  • Past Hx of significant intercranial pathology
  • Pregnant females
  • Blood alcohol level \> 250 mg/dl
  • Non-English speakers (a Spanish version of the ICF is currently being developed)
  • Allergy(s) to soy, egg, or progesterone
  • Active breast or reproductive organ cancer(s)
  • Previous head injury or stroke within the past 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University School of Medicine - Dept. of Emergency Medicine

Atlanta, Georgia, 30322, United States

Location

Related Publications (3)

  • Wright DW, Clark PL, Pentz RD, Hertzberg V, Kellermann AL. Enrolling subjects by exception from consent versus proxy consent in trauma care research. Ann Emerg Med. 2008 Apr;51(4):355-60, 360.e1-3. doi: 10.1016/j.annemergmed.2007.08.021. Epub 2007 Oct 15.

    PMID: 17933428BACKGROUND

  • Wright DW, Kellermann AL, Hertzberg VS, Clark PL, Frankel M, Goldstein FC, Salomone JP, Dent LL, Harris OA, Ander DS, Lowery DW, Patel MM, Denson DD, Gordon AB, Wald MM, Gupta S, Hoffman SW, Stein DG. ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury. Ann Emerg Med. 2007 Apr;49(4):391-402, 402.e1-2. doi: 10.1016/j.annemergmed.2006.07.932. Epub 2006 Sep 29.

    PMID: 17011666RESULT

  • Wright DW, Ritchie JC, Mullins RE, Kellermann AL, Denson DD. Steady-state serum concentrations of progesterone following continuous intravenous infusion in patients with acute moderate to severe traumatic brain injury. J Clin Pharmacol. 2005 Jun;45(6):640-8. doi: 10.1177/0091270005276201.

    PMID: 15901745RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Progesterone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Arthur L Kellermann, MD, MPH

    Chairman - Emory University Dept. of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Investigator, Project Lead

Study Record Dates

First Submitted

November 4, 2002

First Posted

November 6, 2002

Study Start

May 1, 2002

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

US(1)