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New treatment option for Trauma Injury
Official title Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury
ClinicalTrials.gov ID: NCT02577731
What this study is testing
- What it's testing
- Traumatic injury is a leading cause of morbidity and mortality in young adults, and remains a substantial economic and health care burden. Despite decades of promising preclinical and clinical investigations in trauma, investigators understanding of these entities is still incomplete, and few therapies have shown success.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Severe Trauma Population will be:
- All adults (age ≥18 to 54)
- Blunt and/or penetrating trauma resulting in long bone or pelvic fractures requiring ORIF or closed reduction percutaneous pinning (CRPP).
- Blunt and/or penetrating trauma patient with either:
- 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...
You likely can't join if
- will be:
- Patients not expected to survive greater than 48 hours.
- Prisoners.
- Pregnancy.
- Patients receiving chronic corticosteroids or immunosuppression therapies.
- Previous bone marrow transplantation.
See the full eligibility criteria
- Severe Trauma Population will be:
- All adults (age ≥18 to 54)
- Blunt and/or penetrating trauma resulting in long bone or pelvic fractures requiring ORIF or closed reduction percutaneous pinning (CRPP).
- Blunt and/or penetrating trauma patient with either:
- 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
- Or injury severity score (ISS) greater than or equal to 15.
- All adults (age 55 and older) require:
- Blunt and/or penetrating trauma resulting in log bone or pelvic fractures requiring ORIF or CRPP
- Either 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
- Or Injury Severity Score (ISS) greater than or equal to 15.
- Ability to obtain Informed Consent prior to OR repair of injury.
- will be:
- Patients not expected to survive greater than 48 hours.
- Prisoners.
- Pregnancy.
- Patients receiving chronic corticosteroids or immunosuppression therapies.
- Previous bone marrow transplantation.
- Patients with End Stage Renal Disease.
- Patients with any pre-existing hematological disease. Elective Hip Repair Population Inclusion criteria will be:
- All adults (age ≥18)
- Patient undergoing elective hip repair for non-infectious reasons.
- Ability to obtain Informed Consent prior to operation. Exclusion Criteria will be:
- Pregnancy.
- Prisoners.
- Patients receiving chronic corticosteroids or immunosuppression therapies.
- History of receiving Chemotherapy or Radiation within the last 6 months
- Previous bone marrow transplantation 7\. Patients with End Stage Renal Disease 8. Patients with any pre-existing hematological disease
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.