Clinical trial NCT05873959: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Trauma Injury
Trauma, Multiple
Trauma Blunt
Keywords: extremities
arterial replacement
arterial reconstruction
Lead sponsor: Humacyte, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with vascular trauma in the extremities who required arterial replacement or reconstruction and in whom the HAVs have been already implanted on a humanitarian basis between June 2022 and May 2023.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability of the HAV
timeFrame: up to 12 months
measure: Primary patency of the HAV after implantation
timeFrame: 30 days
Secondary outcomes:
measure: Frequency of Adverse Events of Special Interest (AESIs)
timeFrame: up to 12 months
measure: HAV durability
timeFrame: up to 12 months
measure: Rate of affected limb salvage/amputation after implantation
timeFrame: up to 12 months
measure: Patency of the HAV after implantation
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Dnipro
country: Ukraine
facility: Municipal Non-Profit Enterprise ""City Clinical Hospital #16" of the Dnipro City Council"
city: Kyiv
country: Ukraine
facility: Medical Center LLC "CLINIC VERUM EXPERT"
city: Vinnytsia
country: Ukraine
facility: Communal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after E. Pirogov" of the Vinnytsia Regional Council, center of cardiovascular surgery
Study officials:
References:
citation: Sokolov O, Shaprynskyi V, Skupyy O, Stanko O, Yurets S, Yurkova Y, Niklason LE. Use of bioengineered human acellular vessels to treat traumatic injuries in the Ukraine-Russia conflict. Lancet Reg Health Eur. 2023 May 6;29:100650. doi: 10.1016/j.lanepe.2023.100650. eCollection 2023 Jun. No abstract available.
citation: Moore EE, Curi M, Namias N, Kundi R, Lum YW, Fox CJ, Rajani RR, Rasmussen TE, Sokolov O, Niklason LE, Khondker Z, Parikh SJ; CLN-PRO-V005 Investigators and the CLN-PRO-V017 Investigators. Bioengineered Human Arteries for the Repair of Vascular Injuries. JAMA Surg. 2025 Feb 1;160(2):181-188. doi: 10.1001/jamasurg.2024.4893.