NCT03051308

Brief Summary

Compare the functionality of new parathyroid transport solution (NPTS) with University of Wisconsin Solution (UW) on parathyroid glands. Also assess its effects on cell viability, parathormone (PTH) secretion, calcium-sensing receptor (CaSR) and vitamin D receptor (VDR) levels during cold ischemia.

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
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 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

First Submitted

Initial submission to the registry

January 29, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

January 29, 2017

Last Update Submit

February 8, 2017

Conditions

Parathyroid Allotransplantation

Keywords

Parathyroid cell viabilityIschemiaParathyroid allotransplantationVitamin D ReceptorCalcium Sensing Receptor

Outcome Measures

Primary Outcomes (5)

  • Cell viability of Parathyroid cells after isolation process

    After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory. Then the investigators will measure the viability of Parathyroid cells after isolation process.

    0 hour

  • Cell viability of Parathyroid cells after 6 hour of cold ischemia

    After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory. After 6 hours the investigators will measure the viability of Parathyroid cells after isolation process.

    6 hour

  • Cell viability of Parathyroid cells after 12 hour of cold ischemia

    After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory. After 12 hours the investigators will measure the viability of Parathyroid cells after isolation process.

    12 hour

  • Cell viability of Parathyroid cells after 18 hour of cold ischemia

    After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory. After 18 hours the investigators will measure the viability of Parathyroid cells after isolation process.

    18 hour

  • Cell viability of Parathyroid cells after 24 hour of cold ischemia

    After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory. After 24 hours the investigators will measure the viability of Parathyroid cells after isolation process.

    24 hour

Secondary Outcomes (1)

  • Parathormone Release of Parathyroid Cells

    1 day

Study Arms (5)

First Application in Hour 0

EXPERIMENTAL

Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10\^7 cells) at 'First Application in Hour 0' non-cold ischemia tissue group

Combination Product: NPT and UW Solution

First Application in Hour 6

EXPERIMENTAL

Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10\^7 cells) at 'First Application in Hour 6' cold ischemic tissue group

Combination Product: NPT and UW Solution

First Application in Hour 12

EXPERIMENTAL

Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10\^7 cells) at 'First Application in Hour 12' cold ischemic tissue group

Combination Product: NPT and UW Solution

First Application in Hour 18

EXPERIMENTAL

Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10\^7 cells) at 'First Application in Hour 18' cold ischemic tissue group

Combination Product: NPT and UW Solution

First Application in Hour 24

EXPERIMENTAL

Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10\^7 cells) at 'First Application in Hour' 24 cold ischemic tissue group

Combination Product: NPT and UW Solution

Interventions

NPT and UW SolutionCOMBINATION_PRODUCT

Tissue preservation solutions for transplantation

First Application in Hour 0First Application in Hour 12First Application in Hour 18First Application in Hour 24First Application in Hour 6

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have parathyroid hyperplasia due to chronic renal failure.

You may not qualify if:

  • Patients who refused to join the study
  • Patients younger than 18 years and older than 80 years.
  • Patients who have hepatitis B,
  • Patients who have hepatitis C,
  • Patients who have human immunodeficiency virus (HIV).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University Hospital

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Belzer FO, Southard JH. Principles of solid-organ preservation by cold storage. Transplantation. 1988 Apr;45(4):673-6. doi: 10.1097/00007890-198804000-00001. No abstract available.

    PMID: 3282347BACKGROUND

  • Southard JH, van Gulik TM, Ametani MS, Vreugdenhil PK, Lindell SL, Pienaar BL, Belzer FO. Important components of the UW solution. Transplantation. 1990 Feb;49(2):251-7. doi: 10.1097/00007890-199002000-00004.

    PMID: 1689516BACKGROUND

  • Guibert EE, Petrenko AY, Balaban CL, Somov AY, Rodriguez JV, Fuller BJ. Organ Preservation: Current Concepts and New Strategies for the Next Decade. Transfus Med Hemother. 2011;38(2):125-142. doi: 10.1159/000327033. Epub 2011 Mar 21.

    PMID: 21566713BACKGROUND

  • Voigt MR, DeLario GT. Perspectives on abdominal organ preservation solutions: a comparative literature review. Prog Transplant. 2013 Dec;23(4):383-91. doi: 10.7182/pit2013100.

    PMID: 24311404BACKGROUND

MeSH Terms

Conditions

Ischemia

Interventions

University of Wisconsin-lactobionate solution

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Erhan Aysan, Prof. M.D.

    Bezmialem Vakif University

    STUDY DIRECTOR

Central Study Contacts

Erhan Aysan, Prof. M.D.

CONTACT

+902124531700erhanaysan@hotmail.com

Beyza Goncu, Msc

CONTACT

+902124531700bsgoncu@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2017

First Posted

February 13, 2017

Study Start

March 1, 2017

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

February 13, 2017

Record last verified: 2017-02

Locations

TU(1)