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NCT02228057 · ClinicalTrials.gov registry record
Long Term Patency Following Arterial Repair
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 13
- Enrollment target
NCT02228057: Completed study, sponsored by University of Pittsburgh.
NCT02228057 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 13 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02228057 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 13 participants
- Enrollment target
Study Summary
Injury to the blood vessels of the extremities, and more specifically the arteries, can result from fractures and severe crush injuries. It occurs in about 3% of the general population. People affected by blood vessel injuries can have important problems, including cold intolerance, general pain, and weakened function of the associated limb. Even after surgical intervention to repair the affected artery, people may still experience numbness, problems with movement, and an inadequate supply of oxygen to the limb. These symptoms are particularly relevant in the case of forearm arterial repairs because this repair directly affects one of our most vital structures: the hand. Despite available interventions and advances in microsurgical technique, arterial repairs can still result in significant sensory and functional impairment of the hand. Once an artery within the arm is injured, a surgeon's primary goal is to restore blood flow to the hand and prevent functional impairment. Even with a prompt effort to restore hand perfusion, long-term (greater than 6 months) sensory and motor function is hard to predict. Furthermore, sometimes the repaired artery becomes occluded over time. We believe that this occlusion has a direct impact on a patient's perceived pain and cold intolerance at the level of the hand. In this study, we are investigating the occurrence of blood vessel occlusion in the arm after at least 6 months of surgery and the impact of this event. To assess this we will use physical exams, non-invasive tests, duplex doppler ultrasound and questionnaires. Questionnaires, including the DASH (disabilities of the arm, shoulder,and hand), CISS (Cold Intolerance Symptom Severity Questionnaire), and Michigan hand score, will be used to assess pain, sensory, and motor impairments in both the affected and unaffected hand. Functional assessments will include 2-point discrimination, grip strength, pinch strength, capillary refill and range of motion.
Primary Outcome
By using ultrasound, both the ulnar and radial artery will be visualized in both arms and using color ultrasound, we will detect the bloodflow. If no flow is present we will assume that the vessel is occluded.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-02 |
What the finished NCT02228057 record still lists
NCT02228057 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 13 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02228057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02228057 about?
NCT02228057 is a clinical study titled "Long Term Patency Following Arterial Repair". Injury to the blood vessels of the extremities, and more specifically the arteries, can result from fractures and severe crush injuries. It occurs in about 3% of the general population. People affected by blood vessel injuries can have important problems, including cold intolerance, general pain, an...
What is the current status of trial NCT02228057?
This trial is currently completed. The enrollment target is 13 participants. The study started on 2014-08. Estimated completion is 2015-02.
Who is sponsoring clinical trial NCT02228057?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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