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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-01-15

Brief Summary

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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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Detailed Description

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Conditions

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Trauma Trauma Injury Trauma, Multiple Trauma Blunt

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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HAV implantation

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.