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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAV implantation | Biological | HAVs already implanted under humanitarian aid program to repair or reconstruct arteries following an extremity life- or limb-threatening traumatic injury. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of the HAV | To determine the rate of adverse events after impanation | up to 12 months |
| Primary patency of the HAV after implantation | To determine the rate of HAV primary patency at 30 days after implantation | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| HAV durability |
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Inclusion Criteria:
Exclusion Criteria:
• Employees of the sponsor or patients who are employees or relatives of the investigator.
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Municipal Non-Profit Enterprise ""City Clinical Hospital #16" of the Dnipro City Council" | Dnipro | Ukraine | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37213923 | Background | 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. | |
| 39565635 | Result |
| Label | URL |
|---|---|
| Lancet Regional Health Europe | View source |
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To determine the time frame when the HAV has not been removed, replaced, or ligated. |
| up to 12 months |
| Rate of affected limb salvage/amputation after implantation | To determine the rate of affected limb salvage/amputation after HAV implantation | up to 12 months |
| Patency of the HAV after implantation | To determine the rate of HAV patency (primary, primary assisted, and secondary) after implantation | up to 12 months |
| 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 | Ukraine |
| 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):181-189. doi: 10.1001/jamasurg.2024.4893. |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D000081084 | Accidental Injuries |
| D009104 | Multiple Trauma |
| D014949 | Wounds, Nonpenetrating |
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