Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606119
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Traumatic injury followed by critical illness provokes pathophysiologic changes in the bone marrow and the gut that contribute to persistent anemia and changes in the microbiome which significantly impact long-term recovery This project will define the interactions between the stress chronic inflammation bone marrow dysfunction and an altered microbiome which will provide a strong foundation for future clinical interventions to help improve outcomes following severe trauma
Detailed Description:
Trauma remains the leading cause of death among people younger than 46 years of age and is the leading cause of years of potential life lost among those younger than 65 With more lives saved trauma morbidity has increased which has consequently revealed a lack of understanding of the impact of trauma survivorship on the patients quality of life and long-term recovery Severe injury when followed by chronic critical illness leads to persistent anemia and the use of blood transfusions is associated with a linear increase in infectious complications These conditions are due to prolonged bone marrow dysfunction associated with an exaggerated catecholamine response chronic stress and systemic inflammation Our laboratory has conducted human research to establish that there are unique bone marrow transcriptomic differences related to inflammation the innate immune response and known inhibitors of erythropoiesis following trauma The laboratory has also discovered that chronic stress after trauma contributes to persistent anemia with impaired iron and erythropoietin function along with the prolonged loss of hematopoietic stem progenitor cells HSPC from the bone marrow Chronic stress after trauma also induces an altered microbiome with decreased alpha and beta diversity and changes in microbial composition leading to a persistent pathobiome All of these factors influence outcomes We hypothesize that there is a unifying interaction between stress inflammation and the microbiome and this has an overall role in the regulation of HSPC and erythroid progenitor cell fate and function following trauma and critical illness Therefore the overarching goal for this study is to build upon this foundation and expand our understanding of HSPC fate and function following trauma including examining interventions aimed at reducing stressinflammation and restoring the microbiome thus improving long-term outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None