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NCT03993002 · ClinicalTrials.gov registry record · NA

DAMP-Mediated Innate Immune Failure and Pneumonia After Trauma - the Harvard-Longwood (HALO) Campus Area Consortium

A NA study, sponsored by Beth Israel Deaconess Medical Center.

Terminated
Registry status
NA
Development phase
1
Enrollment target

NCT03993002 is a NA study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 1 participants.

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The verdict

NCT03993002, a NA study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.

TERMINATED
Registry status
NA
Development phase
1 participants
Enrollment target

Study Summary

The mortality burden of trauma in the United States is substantial, and is currently the leading cause of death in warfare and in civilians below age 45. Infection and sepsis are leading causes of morbidity and death in early survivors. Pneumonia (PNA) occurs in 17-36% of ventilated trauma patients; far more than non-trauma patients. The long held dogmatic notion of a mechanical predisposition to development of pneumonia in trauma has lacked robust support. However, there is evidence of the innate immune response to injury plays a major role in increasing susceptibility to infection. This application is for support of a Focused Program Award addressing the role that "danger signaling" due to "danger associated molecular patterns" (or DAMPs) derived from somatic tissue injuries play in altering innate immune signaling in the lung in ways that predisposes to PNA. This innate immune response plays a pivotal role in the development and progression of lung inflammation. The organization of the Focused Program Award is into six Projects with collaborators from the Departments of Surgery, Medicine and Anesthesiology at Beth Israel Deaconess Medical Center; the Department of Surgery at Brigham and Women's Hospital and the Departments of Biology and Biological Engineering at Massachusetts Institute of Technology. The human subjects interaction portion of this project is covered in the Human Subjects \& Samples Project of the Award, although the information and tissues obtained from this Project will be shared with the other Projects, and the activities planned for those Projects are outlined in this application.

Interventions

  • OTHER Normoxia with Normocarbia
  • OTHER Normoxia with Hypercarbia
  • OTHER Hyperoxia with Normocarbia
  • OTHER Hyperoxia with Hypercarbia

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2019-11-15
Est. Completion 2021-10-01
Phase NA

What the Registry Record Tells You About NCT03993002

The ClinicalTrials.gov registry entry for NCT03993002 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Normoxia with Normocarbia is the first listed.

NCT03993002 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03993002 about?

NCT03993002 is a clinical study titled "DAMP-Mediated Innate Immune Failure and Pneumonia After Trauma - the Harvard-Longwood (HALO) Campus Area Consortium". The mortality burden of trauma in the United States is substantial, and is currently the leading cause of death in warfare and in civilians below age 45. Infection and sepsis are leading causes of morbidity and death in early survivors. Pneumonia (PNA) occurs in 17-36% of ventilated trauma patients;...

What is the current status of trial NCT03993002?

This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2019-11-15. Estimated completion is 2021-10-01.

What interventions are being tested in trial NCT03993002?

The interventions under investigation include: Normoxia with Normocarbia (OTHER), Normoxia with Hypercarbia (OTHER), Hyperoxia with Normocarbia (OTHER), Hyperoxia with Hypercarbia (OTHER).

Who is sponsoring clinical trial NCT03993002?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.