An observational study in Trauma, Trauma Injury and Trauma, Multiple, sponsored by Humacyte, Inc.. Completed at 3 sites in Ukraine. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Humacyte, Inc. · Observational
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.
139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.
This study's enrollment of 17 is below the median of 200 across 84 observational studies indexed under Multiple Trauma.
Browse Multiple Trauma studies →Humacyte, Inc. is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Compared within Multiple Trauma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Wounds and Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HAVs already implanted under humanitarian aid program to repair or reconstruct arteries following an extremity life- or limb-threatening traumatic injury.
Safety and tolerability of the HAV
To determine the rate of adverse events after impanation
Time frame: up to 12 months
Primary patency of the HAV after implantation
To determine the rate of HAV primary patency at 30 days after implantation
Time frame: 30 days
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.
Time frame: up to 12 months
HAV durability
To determine the time frame when the HAV has not been removed, replaced, or ligated.
Time frame: up to 12 months
Rate of affected limb salvage/amputation after implantation
To determine the rate of affected limb salvage/amputation after HAV implantation
Time frame: up to 12 months
Patency of the HAV after implantation
To determine the rate of HAV patency (primary, primary assisted, and secondary) after implantation
Time frame: up to 12 months
Plan to share: Undecided
Ran from May 2023 to primary completion in May 2023, 0 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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