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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: Clinical Trial NA study, sponsored by Beth Israel Deaconess Medical Center.
NCT03993002 is a NA study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ROS production (output is in relative light units per second (RLU/sec)) using luminol-dependent chemiluminescence, measured every 90 sec over the assay time-course of 60 min. Over thirty surface markers on neutrophil subpopulations, including CD10, CD11b, CD15, CD16, CD45, CD66b, CD45, CD274, CD279, and CD88, at various times after trauma will be analyzed using flow cytometry and CyTOF technology. Where indicated, activation of p38/MK2 intracellular signaling pathway will be analyzed by western
Interventions
- OTHER Normoxia with Normocarbia
- OTHER Normoxia with Hypercarbia
- OTHER Hyperoxia with Normocarbia
- OTHER Hyperoxia with Hypercarbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-11-15 |
| Est. Completion | 2021-10-01 |
| Phase | NA |
Why NCT03993002 stopped before completion
NCT03993002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 4 interventions - of which Normoxia with Normocarbia is the first listed.
NCT03993002 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03993002's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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