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Long Term Patency Following Arterial Repair

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ClinicalTrials.gov Identifier: NCT02228057
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : February 13, 2015
Sponsor:
Information provided by (Responsible Party):
Alexander M Spiess, MD, University of Pittsburgh

Brief 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.


Condition or disease
Upper Extremity Arterial Surgery

Detailed Description:
Vascular injuries of the extremities can result from fractures, severe crush injuries, lacerations, and even iatrogenic causes, such as surgical interventions. Its prevalence is about 3% in the general population with increased incidence during times of war. Patients affected by vascular injuries can have significant morbidities, including cold intolerance, pain, sensory abnormalities, and weakness of the affected limb. Even after repair of the affected artery, patients may still experience paresthesias, motor function abnormalities and pain and cold intolerance. These symptoms are particularly relevant in the case of arm arterial repairs because this repair directly affects the function of the hand. Different techniques of arterial repair have evolved over time. Venous grafts (i.e. saphenous and dorsal hand veins) can be employed to repair the damaged vessel. Although most appropriate for treating long gaps, vein grafts have several disadvantages. There is often a diameter mismatch between the harvested vein and the damaged artery which can compromise the repair site. Furthermore, veins are more compliant and have higher volume storage capabilities than their arterial counterparts. These inherent venous qualities can alter blood flow to the limb causing stasis, turbulence, and eventually, stenosis of the graft. Other methodologies have been developed in an effort to balance the negatives associated with venous grafting, including synthetic graft use, arterial ligation, end-to-side anastomosis, and end-to-end repair. Despite available interventions and advances in microsurgical technique, arterial repair in the arm, can still result in significant functional impairment of the upper extremity. The hand is highly perfused with a dual arterial system that arches across the dorsal and palmar surface of the hand. Once an upper extremity artery is compromised, a surgeon's primary goal is to restore blood flow to the hand so as to prevent impairment. Despite a surgeon's best efforts, long term (greater than 6 months) outcomes are hard to predict. Furthermore, the patency rates of the arterial repair have been consistently reported at approximately 50%. We believe that the long term patency of the upper extremity artery has a direct effect on a patient's perceived pain and cold intolerance, sensibility, and motor function of the hand. Our hypothesis is that repaired arteries in the upper extremity will have an occlusion rate of 50% in the long term (greater than 6 months post-surgery) and that this occlusion is responsible for motor and sensory function abnormalities, pain, and cold-intolerance. We will use high resolution duplex Doppler ultrasound to investigate occlusion rates of repaired arteries and compare those to the unaffected contralateral arteries (internal control). 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, cold intolerance, 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.

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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Patency Following Arterial Repair
Study Start Date : August 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Group/Cohort
operated group
all patients who had upper extremity artery surgery at least 6 months ago



Primary Outcome Measures :
  1. relationship of time after arterial repair with patency of the vessel [ Time Frame: at least 6 months after surgery ]
    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.


Secondary Outcome Measures :
  1. Correlation between arterial patency and cold intolerance. [ Time Frame: at least 6 months after surgery ]
    Both hands will be assessed for cold intolerance. To assess this we will use the CISS questionnaire (Cold Intolerance Symptom Severity Questionnaire).

  2. Correlation between arterial patency and digital sensibility. [ Time Frame: at least 6 months after surgery ]
    Both hands will be assessed for sensibility. To assess this we will use physical exams and questionnaires. Questionnaires, including the DASH (disabilities of the arm, shoulder,and hand) and Michigan hand score will be used to assess sensibility in both the affected and unaffected hand. A functional assessment for sensibility will be the 2-point discrimination.

  3. Correlation between arterial patency and hand strength. [ Time Frame: at least 6 months after surgery ]
    Functional assessments will include grip strength and pinch strength.

  4. Correlation between arterial patency and capillary refill [ Time Frame: at least 6 months after surgery ]
    Vascular assessment will include capillary refill.

  5. Correlation between arterial patency and range of movement of the fingers [ Time Frame: at least 6 months after surgery ]
    Functional assessments will include the measurement of the distance of the fingertips to the distal palmar crease when the fingers are maximally flexed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients that underwent upper extremity arterial surgery and are at least 6 months out of surgery.
Criteria

Inclusion Criteria:

Patients meeting the following criteria will be eligible to participate in this study:

  1. Age 18 and over
  2. Able to provide informed consent
  3. Have previously underwent surgery for an arm arterial repair
  4. Be at least 6 months post-arterial repair
  5. Willing and able to comply with follow-up tests/procedures and questionnaires

Exclusion Criteria:

Patients meeting the following criteria will be excluded from this study:

  1. Age less than 18 years
  2. Unable to provide informed consent
  3. Nerve repair in extremity of interest
  4. Any condition which compromises the contralateral hand to serve as a reliable internal control

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228057


Locations
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United States, Pennsylvania
University of Pittsburgh Scaife Hall
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Alexander M. Spiess, MD University of Pittsburgh

Publications:

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Responsible Party: Alexander M Spiess, MD, Dr., University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02228057     History of Changes
Other Study ID Numbers: PRO12010024
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015
Keywords provided by Alexander M Spiess, MD, University of Pittsburgh:
arterial patency
upper extremity
anastomosis
sensibility
pain
cold intolerance