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

Primary Purpose

Injury of Radial Artery at Wrist and Hand Level, Injury; Ulnar Artery, Hand and Wrist

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
vessel microsurgery
tendon repair
nerve microsurgery
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injury of Radial Artery at Wrist and Hand Level focused on measuring CD34, CD133, CD309, Radial Artery, Ulnar Artery, Lymphoid Cell, blood levels, endothelial progenitor cells, stem cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erciyes University Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

having arteriel cut

having tendon cut

healthy control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

flow velocity of vessel measure with doppler ultrasonography (cm/sn)
the patients will be divided 4 groups with flow velocity
CD 34 - 133 - 309 measurement with immunohistochemical techniques (piece)
CD 34 - 133 - 309 levels will be compared between groups
vessel diameter measure with doppler ultrasonography (cm)
the patients will be divided 4 groups with vessel diameter

Secondary Outcome Measures

Full Information

First Posted
March 14, 2015
Last Updated
October 10, 2016
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT02421081
Brief Title
Effect of Cell Surface Markers and Lymphoid Cell Distribution on the Arterial Tissue Repair (ECLAR)
Acronym
ECLAR
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 Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury of Radial Artery at Wrist and Hand Level, Injury; Ulnar Artery, Hand and Wrist
Keywords
CD34, CD133, CD309, Radial Artery, Ulnar Artery, Lymphoid Cell, blood levels, endothelial progenitor cells, stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
having arteriel cut
Arm Type
Active Comparator
Arm Description
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.
Arm Title
having tendon cut
Arm Type
Active Comparator
Arm Description
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.
Arm Title
healthy control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
vessel microsurgery
Other Intervention Name(s)
anastomosis, artery repair
Intervention Description
That is a surgery ro repair artery laceration.
Intervention Type
Procedure
Intervention Name(s)
tendon repair
Intervention Description
That is a surgery ro repair tendon cut.
Intervention Type
Procedure
Intervention Name(s)
nerve microsurgery
Intervention Description
That is a surgery ro repair median/ ulnar/ radial nerve cut.
Primary Outcome Measure Information:
Title
flow velocity of vessel measure with doppler ultrasonography (cm/sn)
Description
the patients will be divided 4 groups with flow velocity
Time Frame
flow velocity will measure from lacere arter distal and whole arter; pre surgery, and 4. week after surgery
Title
CD 34 - 133 - 309 measurement with immunohistochemical techniques (piece)
Description
CD 34 - 133 - 309 levels will be compared between groups
Time Frame
6 hours after trauma
Title
vessel diameter measure with doppler ultrasonography (cm)
Description
the patients will be divided 4 groups with vessel diameter
Time Frame
vessel diameter will measure from lacere arter distal and whole arter; pre surgery, and 4. week after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be chosen Older from 18 year Don't use any medicine Exclusion Criteria: younger from 18 years Having another illness Using medicine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Eray GUNAY, MD,resident
Phone
+905556493401
Email
alieraygunay@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
İbrahim KARAMAN, docent
Phone
05327183353
Email
drikaraman@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İbrahim KARAMAN, docent
Organizational Affiliation
TC Erciyes University
Official's Role
Study Director
Facility Information:
Facility Name
Erciyes University Faculty of Medicine
City
Melikgazi
State/Province
Kayseri
ZIP/Postal Code
38050
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Eray GUNAY, resisdent
Phone
+905556493401
Email
alieraygunay@hotmail.com
First Name & Middle Initial & Last Name & Degree
İbrahim KARAMAN, docent
Phone
05327183353
Email
drikaraman@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
12234281
Citation
Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. doi: 10.1111/j.1523-1755.2002.kid551.x.
Results Reference
result
PubMed Identifier
3052352
Citation
Glagov S, Zarins C, Giddens DP, Ku DN. Hemodynamics and atherosclerosis. Insights and perspectives gained from studies of human arteries. Arch Pathol Lab Med. 1988 Oct;112(10):1018-31.
Results Reference
result
PubMed Identifier
9351396
Citation
Mattsson EJ, Kohler TR, Vergel SM, Clowes AW. Increased blood flow induces regression of intimal hyperplasia. Arterioscler Thromb Vasc Biol. 1997 Oct;17(10):2245-9. doi: 10.1161/01.atv.17.10.2245.
Results Reference
result
PubMed Identifier
9288132
Citation
Guzman RJ, Abe K, Zarins CK. Flow-induced arterial enlargement is inhibited by suppression of nitric oxide synthase activity in vivo. Surgery. 1997 Aug;122(2):273-9; discussion 279-80. doi: 10.1016/s0039-6060(97)90018-0.
Results Reference
result
PubMed Identifier
11774107
Citation
Dixon BS, Novak L, Fangman J. Hemodialysis vascular access survival: upper-arm native arteriovenous fistula. Am J Kidney Dis. 2002 Jan;39(1):92-101. doi: 10.1053/ajkd.2002.29886.
Results Reference
result
PubMed Identifier
12821589
Citation
Szmitko PE, Fedak PW, Weisel RD, Stewart DJ, Kutryk MJ, Verma S. Endothelial progenitor cells: new hope for a broken heart. Circulation. 2003 Jun 24;107(24):3093-100. doi: 10.1161/01.CIR.0000074242.66719.4A. No abstract available.
Results Reference
result
PubMed Identifier
12829619
Citation
Werner N, Junk S, Laufs U, Link A, Walenta K, Bohm M, Nickenig G. Intravenous transfusion of endothelial progenitor cells reduces neointima formation after vascular injury. Circ Res. 2003 Jul 25;93(2):e17-24. doi: 10.1161/01.RES.0000083812.30141.74. Epub 2003 Jun 26.
Results Reference
result
PubMed Identifier
14597586
Citation
Griese DP, Ehsan A, Melo LG, Kong D, Zhang L, Mann MJ, Pratt RE, Mulligan RC, Dzau VJ. Isolation and transplantation of autologous circulating endothelial cells into denuded vessels and prosthetic grafts: implications for cell-based vascular therapy. Circulation. 2003 Nov 25;108(21):2710-5. doi: 10.1161/01.CIR.0000096490.16596.A6. Epub 2003 Nov 3.
Results Reference
result
PubMed Identifier
11156872
Citation
Kawamoto A, Gwon HC, Iwaguro H, Yamaguchi JI, Uchida S, Masuda H, Silver M, Ma H, Kearney M, Isner JM, Asahara T. Therapeutic potential of ex vivo expanded endothelial progenitor cells for myocardial ischemia. Circulation. 2001 Feb 6;103(5):634-7. doi: 10.1161/01.cir.103.5.634.
Results Reference
result
PubMed Identifier
12241713
Citation
Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T; Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet. 2002 Aug 10;360(9331):427-35. doi: 10.1016/S0140-6736(02)09670-8.
Results Reference
result

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

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