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Stem Cell Response After Traumatic Injury in the Elderly

N/A

Recruiting

Led By Philip Efron, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All adults (age ≥18 to 54) with blunt and/or penetrating trauma resulting in long bone or pelvic fractures requiring ORIF or CRPP

Blunt and/or penetrating trauma patients with hemorrhagic shock defined by: i. systolic BP (SBP) ≤ 90 mmHg or ii. mean arterial pressure ≤ 65 mmHg or iii. base deficit (BD) ≥ 5 meq or iv. lactate ≥ 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 8 months

Awards & highlights

Study Summary

This trialexplores how severe trauma can cause a rapid release of stem cells from the bone marrow which can lead to muscle loss and increased risk of infection.

Who is the study for?

This trial is for adults aged 55 and older with severe trauma from blunt or penetrating injuries, showing signs of hemorrhagic shock or having a high injury severity score. It also includes younger adults (18-54) with similar injuries requiring surgery. Excluded are those not expected to survive 48 hours, prisoners, pregnant women, patients with end-stage renal disease, hematological diseases, prior bone marrow transplants, or recent chemotherapy/radiation.Check my eligibility

What is being tested?

The study investigates how severe injury affects stem cells in the elderly by collecting blood and bone marrow samples and clinical data. Researchers aim to understand 'emergency myelopoiesis'—the body's response to replenish immune cells after trauma—and its link to muscle loss and infection risk post-injury.See study design

What are the potential side effects?

Since this trial involves non-medication interventions like blood and bone marrow collection rather than drug testing, typical side effects related to medication are not applicable. However, there may be general risks associated with these procedures such as pain at the collection site or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult between 18 and 54 with a serious fracture needing surgery.

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I have experienced severe blood loss due to trauma, indicated by low blood pressure or high lactate levels.

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I am 55 or older and need surgery for a major bone or pelvic fracture.

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I have experienced severe blood loss due to trauma, indicated by low blood pressure or high lactate levels.

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I have had a serious injury with a severity score of 15 or more.

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I can sign a consent form before my surgery or injury repair.

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I am an adult having elective hip surgery for a non-infectious reason.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Analyze the genomics response of hematopoietic cells between the groups

Analyze the muscle dysfunction between the groups for apoptosis

Analyze the muscle dysfunction between the groups for autophagy

+2 more

Secondary outcome measures

The pathophysiology of injury-associated persistent anemia through ELISA test of blood.

The pathophysiology of injury-associated persistent anemia through PB colony assays of blood.

Other outcome measures

Analyze the genomics response of hematopoietic cells between the groups at additional follow-up surgery

Analyze the muscle dysfunction between the groups at additional follow-up surgery for apoptosis

Analyze the muscle dysfunction between the groups at additional follow-up surgery for autophagy

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Severe TraumaExperimental Treatment3 Interventions

Bone marrow collection. Blood collection. Clinical data collection.

Group II: Healthy Young Bone Marrow ControlExperimental Treatment1 Intervention

Deidentified freshly isolated bone marrow samples from healthy young control subjects will be purchased for a tissue bank.

Group III: Elective Hip RepairExperimental Treatment3 Interventions

Bone marrow collection. Blood collection. Clinical data collection.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of General Medical Sciences (NIGMS)NIH

271 Previous Clinical Trials

246,620 Total Patients Enrolled

University of FloridaLead Sponsor

1,349 Previous Clinical Trials

719,729 Total Patients Enrolled

Philip Efron, MDPrincipal InvestigatorUniversity of Florida

6 Previous Clinical Trials

1,944 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant quota for this research endeavor?

"Absolutely, the available evidence on clinicaltrials.gov attests to this medical trial's current state of recruitment. Announced in early January 2014 and recently updated in late October 2022, the study is looking for 400 subjects from a single location."

Answered by AI

Does this research protocol currently have open enrollment?

"Yes, as per clinicaltrials.gov records, this medical trial is currently recruiting participants. The study was initially posted on January 1st 2014 and modified most recently on October 27th 2022. 400 patients are being sought from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury

2014. "Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02577731.