Trauma Clinical Trial
Official title:
A Phase 2/3 Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients With Life or Limb-threatening Vascular Trauma
This study evaluates the use of the Human Acellular Vessel (HAV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be a torso cohort and a limb cohort. All subjects will be implanted with a HAV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.
This is a prospective, multicenter, multi cohort, non-randomized phase 2 study in up to 40 adult patients with life or limb threatening vascular trauma which requires surgical repair. There will be a limb cohort and a torso cohort. The limb cohort will include patients who require repair of a vessel contained to the upper or lower extremity. The torso cohort includes patients who require repair of vessels within the thorax (excluding the heart), abdomen, and retroperitoneum. Subjects will be implanted with a Humacyte Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm. The active study duration for each study participant will be 36 months from HAV implantation or until HAV failure/ removal/ death if earlier. Follow up after month 12 will involve the capture of information on assessments performed at "standard of care" routine clinic visits or by telephone follow up with the patient or his/her physician with physical exam and ultrasound at month 24 and month 36 The total expected duration of the clinical study is 61 months (24 months of enrollment and 36 months of follow up). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Terminated |
NCT03781817 -
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
|
Phase 4 | |
Completed |
NCT04342416 -
Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
|
N/A | |
Recruiting |
NCT04856449 -
DBT Skills Plus EMDR for BPD and Trauma
|
N/A | |
Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
Completed |
NCT05669313 -
The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
|
||
Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
Recruiting |
NCT04725721 -
Testing FIRST in Youth Outpatient Psychotherapy
|
N/A | |
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
Not yet recruiting |
NCT03696563 -
FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
|
N/A | |
Withdrawn |
NCT03249129 -
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
|
||
Completed |
NCT02240732 -
Surgical Tourniquets and Cerebral Emboli
|
N/A | |
Completed |
NCT02227979 -
Effects of PURPLE Cry Intervention
|
N/A | |
Withdrawn |
NCT01169025 -
Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients
|
N/A | |
Recruiting |
NCT01812941 -
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
|
N/A | |
Completed |
NCT01475344 -
Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
|
Phase 1/Phase 2 | |
Completed |
NCT03112304 -
Child STEPS for Youth Mental Health in Maine Sustainability
|
N/A | |
Completed |
NCT01201863 -
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
|
Phase 4 | |
Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A |