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Effect of Cell Surface Markers and Lymphoid Cell Distribution on the Arterial Tissue Repair (ECLAR) (ECLAR)

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ClinicalTrials.gov Identifier: NCT02421081
Recruitment Status : Unknown
Verified October 2016 by ali eray günay, TC Erciyes University.
Recruitment status was:  Recruiting
First Posted : April 20, 2015
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
ali eray günay, TC Erciyes University

Brief Summary:
The radial and ulnar artery injuries related with the wrist cut are frequently encountered. There are many factors which are effective on the improvement of these arterial structures was repaired with microsurgical techniques. Recently has begun to focus on neointimal thickening and endothelialization of the role in vascular healing and maturation made on histopathological study. In this study, the radial and ulnar artery laceration repair healing with the microsurgical anastomosis methods on blood CD34, CD133 and CD309 levels of the effect of the distribution of lymphoid cells has been investigated. The investigators think that; thus by demonstrating the positive impact that may arise; autologous endothelial progenitor cells which are obtained in patients; continuation of anastomotic patency undergoing coronary by-pass or the in hemodialysis patients with arteriovenous fistula; also ensuring the re-flow in patients with acute and chronic peripheral arterial occlusion. The investigators believe could be used for the reimplanted tissue in the limb breakage ensuring that survive.

Condition or disease Intervention/treatment Phase
Injury of Radial Artery at Wrist and Hand Level Injury; Ulnar Artery, Hand and Wrist Procedure: vessel microsurgery Procedure: tendon repair Procedure: nerve microsurgery Not Applicable

Detailed Description:

The radial and ulnar arteries cuts that need to be urgently repaired using microsurgical techniques; after treatment failure rate is quite high among the injured. When straight cut repaired with microsurgical instruments under the microscope cut properly; can be obtained close to excellent results. However, there are many factors that impact on the arterial healing. Hypertension, hypotension, age, diabetes mellitus, obesity and female gender has negative effects on the vascular healing. In recent years, positive effects of endothelialization begun to focus on the improvement; and has been shown to endothelialization on the hematopoietic stem cells and endothelial progenitor cells CD34 and CD133 cd309 is effective. CD34 is a type 1 transmembrane protein and is known as the stem cell marker. Proliferative cells and endothelial stem cells play an important role still in the healing process after vascular incisions. These include CD133 (haematopoietic progenitor cells) and CD309 (Vasculoendotelial Growth Factor Receptor 2) is also believed to be effective. These stem cells and proliferating endothelial cells is called collectively endothelial proliferative cells (EPC). Griese et al in a study had been done on rabbits; autologous endothelial cells, obtained from peripheral blood with immunohistochemical methods, were transplanted after carotid artery intimal injury experimentally.The EPC-treated group was observed that increased endothelialization and significantly reduced neointimal hyperplasia, compared to the control group. Kawamoto et al in their study ex vivo; endothelial progenitor cells in the myocardial ischemic group, has been shown to have positive impact on the preservation of left ventricular function. In another clinical study in patients with peripheral arterial disease with ischemic limbs; increase of oxygen carried in the extremities in the study group, decrease in rest pain, increase in walk distance and had an increase in ankle-brachial index.

In the investigators study on the vessel laceration, such as CD 34, CD133 and CD309 endothelial progenitor cells and stem cells in the blood levels will show whether the effects on vascular healing. Results to be obtained; frequently encountered and the relatively high treatment costs and lead to the loss also great labor; myocardial infarction, peripheral arterial disease, ensuring the fistula opening in chronic dialysis patients, provision of limb preservation and vitality of limb replantation will open up new horizons.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Cell Surface Markers Like CD 34 - CD 133 - CD 309 and Lymphoid Cell Distribution on the Wrist Laceration With Radial or Ulnar Arterial Tissue Repair
Study Start Date : August 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: having arteriel cut
30 patients who refer to Erciyes University emergency department because of wrist laceration with radial and/or ulnar artery incision,will be presenting to the study.All patient's flow rate will be evaluated by Doppler ultrasonography before surgery,as well as the healthy side and side of the cuts.Then 5 ml of blood samples will be taken from the systemic circulation,flowcytometric analysis of serum CD34,CD133 and CD309 levels to be measured.Then after patients received surgery,under a microscope using microsurgical techniques and polyamide suture will be held vascular repair.Patients will be assessed by Doppler ultrasonography again 4 weeks after surgery;flow velocity and vessel diameter will be measured at the anastomoses line and patient will be divided to 4 groups. Among these groups serum CD34,CD133,CD309 levels and distribution of lymphoid cells measured by immunohistochemistry; The relationship between the anastomosis opening will be evaluated statistically.
Procedure: vessel microsurgery
That is a surgery ro repair artery laceration.
Other Names:
  • anastomosis
  • artery repair

Procedure: tendon repair
That is a surgery ro repair tendon cut.

Procedure: nerve microsurgery
That is a surgery ro repair median/ ulnar/ radial nerve cut.

Active Comparator: having tendon cut
10 patients having similar age and sex with first group, who refer to Erciyes University emergency department because of wrist laceration without radial or ulnar artery cutting,will be taken to compare with first group.All patient's flow rate will be evaluated by Doppler ultrasonography before surgery,as well as the healthy side and side of the cuts.Then 5 ml of blood samples will be taken from the systemic circulation,flowcytometric analysis of serum CD34,CD133 and CD309 levels to be measured.Then after patients received surgery to repair tendons and/or nerves. Among these groups serum CD34,CD133,CD309 levels and distribution of lymphoid cells measured by immunohistochemistry; and will compare with first group.
Procedure: tendon repair
That is a surgery ro repair tendon cut.

Procedure: nerve microsurgery
That is a surgery ro repair median/ ulnar/ radial nerve cut.

No Intervention: healthy control
10 healty having similar age and sex with first group,controls who accept to give blood to determine normal range of serum CD34,CD133 and CD 309 will be taken to compare with first group.All patient's flow rate will be evaluated by Doppler ultrasonography.Then 5 ml of blood samples will be taken from the systemic circulation,flowcytometric analysis of serum CD34,CD133 and CD309 levels to be measured.



Primary Outcome Measures :
  1. flow velocity of vessel measure with doppler ultrasonography (cm/sn) [ Time Frame: flow velocity will measure from lacere arter distal and whole arter; pre surgery, and 4. week after surgery ]
    the patients will be divided 4 groups with flow velocity

  2. CD 34 - 133 - 309 measurement with immunohistochemical techniques (piece) [ Time Frame: 6 hours after trauma ]
    CD 34 - 133 - 309 levels will be compared between groups

  3. vessel diameter measure with doppler ultrasonography (cm) [ Time Frame: vessel diameter will measure from lacere arter distal and whole arter; pre surgery, and 4. week after surgery ]
    the patients will be divided 4 groups with vessel diameter



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will be chosen

  1. Older from 18 year
  2. Don't use any medicine

Exclusion Criteria:

  1. younger from 18 years
  2. Having another illness
  3. Using medicine

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): NCT02421081


Contacts
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Contact: Ali Eray GUNAY, MD,resident +905556493401 alieraygunay@hotmail.com
Contact: İbrahim KARAMAN, docent 05327183353 drikaraman@gmail.com

Locations
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Turkey
Erciyes University Faculty of Medicine Recruiting
Melikgazi, Kayseri, Turkey, 38050
Contact: Ali Eray GUNAY, resisdent    +905556493401    alieraygunay@hotmail.com   
Contact: İbrahim KARAMAN, docent    05327183353    drikaraman@gmail.com   
Sponsors and Collaborators
TC Erciyes University
Investigators
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Study Director: İbrahim KARAMAN, docent TC Erciyes University
Publications of Results:

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Responsible Party: ali eray günay, resident, TC Erciyes University
ClinicalTrials.gov Identifier: NCT02421081    
Other Study ID Numbers: IKCD
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Keywords provided by ali eray günay, TC Erciyes University:
CD34
CD133
CD309
Radial Artery
Ulnar Artery
Lymphoid Cell
blood levels
endothelial progenitor cells
stem cells
Additional relevant MeSH terms:
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Wounds and Injuries