Clinical Trials Logo
  1. Home
  2. Trauma
  3. NCT05873959
  4. Details
NCT05873959 Clinical Trial

An Observational Study to Evaluate the Safety and Efficacy of Humacyte's HAV for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma

Trauma Clinical Trial

Official title:
An Observational Multicenter Study to Evaluate the Safety and Efficacy of Humacyte's Human Acellular Vessel in a Real World Setting for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05873959
Other study ID # CLN-PRO-V017
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 31, 2023
Est. completion date May 2024

Study information
Verified date February 2024
Source Humacyte, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Humacyte provided HAVs as humanitarian aid to Ukraine. This retrospective observational study is designed to collect data from patients in whom the HAVs have already been implanted on a humanitarian basis between June 2022 and May 2023.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 17
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Patients with an HAV implanted to repair or reconstruct an arterial vessel following life- or limb-threatening traumatic vascular injury of an extremity. - Aged 18 to 85 years old, inclusive. - Patient or legal representative is able, willing, and competent to give informed consent. Exclusion Criteria: • Employees of the sponsor or patients who are employees or relatives of the investigator.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• HAV implantation
HAVs already implanted under humanitarian aid program to repair or reconstruct arteries following an extremity life- or limb-threatening traumatic injury.

Locations
Country Name City State
Ukraine Municipal Non-Profit Enterprise ""City Clinical Hospital #16" of the Dnipro City Council" Dnipro
Ukraine Medical Center LLC "CLINIC VERUM EXPERT" Kyiv
Ukraine Communal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after E. Pirogov" of the Vinnytsia Regional Council, center of cardiovascular surgery Vinnytsia

Sponsors (1)
Lead Sponsor Collaborator
Humacyte, Inc.

Country where clinical trial is conducted

Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability of the HAV To determine the rate of adverse events after impanation up to 12 months
Primary Primary patency of the HAV after implantation To determine the rate of HAV primary patency at 30 days after implantation 30 days
Secondary Frequency of Adverse Events of Special Interest (AESIs) To determine the rate of Adverse Events of Special Interest (AESIs), such as: thrombosis, clinically significant aneurysm or pseudoaneurysm formation, HAV spontaneous rupture, infection of the HAV conduit, and HAV abandonment. up to 12 months
Secondary HAV durability To determine the time frame when the HAV has not been removed, replaced, or ligated. up to 12 months
Secondary Rate of affected limb salvage/amputation after implantation To determine the rate of affected limb salvage/amputation after HAV implantation up to 12 months
Secondary Patency of the HAV after implantation To determine the rate of HAV patency (primary, primary assisted, and secondary) after implantation up to 12 months
See also
  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 NCT01210417 - Trauma Heart to Arm Time N/A
Completed NCT01201863 - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy Phase 4

External Links