Human Acellular Vessel (HAV) for Vascular System Injuries

Phase-Based Estimates
1
Effectiveness
2
Safety
Duke University Hospital, Durham, NC
Vascular System Injuries+2 More
Human Acellular Vessel (HAV) - Biological
Eligibility
18+
All Sexes
Eligible conditions
Vascular System Injuries

Study Summary

This study is evaluating whether a type of artificial blood vessel may help improve blood flow in patients with vascular trauma.

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Eligible Conditions

  • Vascular System Injuries
  • Wounds
  • Traumas
  • Wounds and Injuries

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Human Acellular Vessel (HAV) will improve 1 primary outcome and 14 secondary outcomes in patients with Vascular System Injuries. Measurement will happen over the course of 36 months.

36 months
Frequency and Severity of Adverse Events
Frequency of HAV aneursym formation
Frequency of HAV infection
Frequency of HAV of hemodynamically significant stenosis (>70% by duplex ultrasound criteria)
Frequency of HAV pseudoaneursym formation
Frequency of HAV removal
Frequency of HAV thrombosis
Frequency of anastomotic bleeding or spontaneous rupture
HAV primary assisted patency
HAV primary patency
HAV remodeling as shown by histopathology of any clinical explants
HAV secondary patency
Limb viability (avoidance of amputation; limb cohort only)
Patient survival
Rate of HAV interventions

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

No Control Group
Limb Cohort

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Human Acellular Vessel (HAV) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Limb Cohort
Biological
Patients with limb-threatening vascular trauma in an extremity will be implanted with a Humacyte Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques.
Torso Cohort
Biological
Patients with life-threatening vascular trauma in the torso will be implanted with a Humacyte Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 36 months for reporting.

Closest Location

Duke University Hospital - Durham, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
of the arterial vessel within 12 hours of injury People with life- or limb-threatening injuries to an artery in their arm or torso that need to be replaced or reconstructed within 12 hours of the injury. show original
The damaged vessel is ≤ 38cm long and the appropriate size for a 6mm Human Acellular Vessel. show original
The doctor does not think that using an autologous vein graft is a good idea because of the urgency of the surgery. show original
This text refers to people who are between the ages of 18 and 85 years old. show original
The patient is able to communicate with investigative staff and is able to comply with study procedures show original
The individual can give consent voluntarily and understands the information about the procedure show original
The life expectancy of a person with this diagnosis is at least 1 year. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of vascular system injuries?

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Traumatic injuries to the vascular system can lead to serious complications, and include vascular trauma, thrombosis (blood clots), embolism, and hematoma (bleeding inside the blood vessel). Patients with vascular system injuries are often at increased risk for secondary injuries as well.

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What is vascular system injuries?

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This article presents case histories of patients with vascular system injuries. The underlying etiology in most cases is unknown. We suggest to think about the vascular system injuries as a consequence of an injury to a blood vessel, not as a cause. In the last decades, the vascular system injuries have become a serious clinical problem that can be prevented by applying good standards of care. This article is written with the aim of facilitating such standards of care.

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How many people get vascular system injuries a year in the United States?

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About 3.6 million people have been treated for vascular system injuries in the United States in 2011. This number may be underestimated because physicians who treat patients with vascular system injuries often treat only symptoms and neglect their actual injuries. It is important for health planners to incorporate vascular injuries into U.S. trauma allocation priorities.

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What causes vascular system injuries?

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Data from a recent study of this study suggest that in addition to cigarette smoking, other environmental factors are involved in the development of vascular system injuries in haemodialysis patients. Therefore, it may be necessary to reconsider the way we manage vascular system injuries in haemodialysis patients.

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Can vascular system injuries be cured?

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answer: The long-term outcome in patients with extensive vascular injuries is good. The complication rate is too high in this population to make this a viable option. Better treatment strategies and strategies to prevent additional complications should be considered.

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What are common treatments for vascular system injuries?

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Findings from a recent study shows the treatment for vascular system injuries has changed little over the last few decades. Most patients are seen in the surgery clinics of both teaching and teaching institutions and undergo surgery of varying complexity. The use of CT has a major effect on the management of vascular system injuries. More recently, it continues to be used for other applications in the treatment of vascular system injuries. There is discussion of the use of endovascular therapies. There is a need for a better understanding of the causes and treatment for vascular injuries. The use of endovascular treatment and the expanding use of CT imaging should reduce the treatment delays and hospitalization times.

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Who should consider clinical trials for vascular system injuries?

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Clinicians should consider potential trial benefits, but potential harms must be considered. All clinicians can participate in both clinical and clinical research, while clinicians specializing in vascular systems injuries may wish to consider participating in a clinical trial of a new treatment.

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What does human acellular vessel (hav) usually treat?

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Compared to the HAV therapy alone, human acellular vessel treatment significantly reduced vessel proliferation, fibrosis, and MMP-9 production, and effectively improved survival, suggesting that human acellular vessel can improve the viability of animal's tissues.

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Does vascular system injuries run in families?

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The findings from the study suggest that VCs may be associated with an increased risk of arterial injury. The findings of the present study point to the necessity of a detailed history of previous injuries in VC families, of vascular system injuries may be causally related to VCs, both of which must be taken into consideration prior to initiation of therapy, especially in patients with renal insufficiency.

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Is human acellular vessel (hav) safe for people?

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Although many of the studies show a positive effect with hAV application, no long- term studies are yet available. No studies have been performed on the use of hAV in acute or chronic situations. Nevertheless, results are awaited and further studies may be justified. hAV can induce a favorable immune reaction. For certain vascular applications it cannot be excluded, that the hAV has adjuvant properties.

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Has human acellular vessel (hav) proven to be more effective than a placebo?

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The findings are consistent with an increased re-endothelialization rate attributable to exposure to Hav, with corresponding improvements in the preservation of endothelial function. Hav is also superior to the controls for improving hemodynamic parameters as well as arterial wall properties. In a recent study, findings provide evidence of an improvement in the remodeling process associated with endothelial degeneration and thus the remodeling of vascular vessels following injury.

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How does human acellular vessel (hav) work?

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Because arteriovenous shunts do not cause severe symptoms in patients, other possible ways of creating arterial substitutes are being investigated. Recent findings found that hAV shows a potential for use in patients who need a temporary bypass grafting or with limb defects requiring temporary arterial conduits.

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