NCT02421081

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

March 14, 2015

Last Update Submit

October 10, 2016

Conditions

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

Keywords

CD34CD133CD309Radial ArteryUlnar ArteryLymphoid Cellblood levelsendothelial progenitor cellsstem cells

Outcome Measures

Primary Outcomes (3)

  • flow velocity of vessel measure with doppler ultrasonography (cm/sn)

    the patients will be divided 4 groups with flow velocity

    flow velocity will measure from lacere arter distal and whole arter; pre surgery, and 4. week after surgery

  • CD 34 - 133 - 309 measurement with immunohistochemical techniques (piece)

    CD 34 - 133 - 309 levels will be compared between groups

    6 hours after trauma

  • vessel diameter measure with doppler ultrasonography (cm)

    the patients will be divided 4 groups with vessel diameter

    vessel diameter will measure from lacere arter distal and whole arter; pre surgery, and 4. week after surgery

Study Arms (3)

having arteriel cut

ACTIVE COMPARATOR

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 microsurgeryProcedure: tendon repairProcedure: nerve microsurgery

having tendon cut

ACTIVE COMPARATOR

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 repairProcedure: nerve microsurgery

healthy control

NO INTERVENTION

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.

Interventions

vessel microsurgeryPROCEDURE

That is a surgery ro repair artery laceration.

Also known as: anastomosis, artery repair
having arteriel cut
tendon repairPROCEDURE

That is a surgery ro repair tendon cut.

having arteriel cuthaving tendon cut
nerve microsurgeryPROCEDURE

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

having arteriel cuthaving tendon cut

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients will be chosen
  • Older from 18 year
  • Don't use any medicine

You may not qualify if:

  • younger from 18 years
  • Having another illness
  • Using medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Faculty of Medicine

Melikgazi, Kayseri, 38050, Turkey (Türkiye)

RECRUITING

Related Publications (10)

  • 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.

    PMID: 12234281RESULT

  • 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.

    PMID: 3052352RESULT

  • 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.

    PMID: 9351396RESULT

  • 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.

    PMID: 9288132RESULT

  • 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.

    PMID: 11774107RESULT

  • 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.

    PMID: 12821589RESULT

  • 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.

    PMID: 12829619RESULT

  • 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.

    PMID: 14597586RESULT

  • 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.

    PMID: 11156872RESULT

  • 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.

    PMID: 12241713RESULT

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Anastomosis, Surgical

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • İbrahim KARAMAN, docent

    TC Erciyes University

    STUDY DIRECTOR

Central Study Contacts

Ali Eray GUNAY, MD,resident

CONTACT

+905556493401alieraygunay@hotmail.com

İbrahim KARAMAN, docent

CONTACT

05327183353drikaraman@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

March 14, 2015

First Posted

April 20, 2015

Study Start

August 1, 2014

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

TU(1)