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临床试验/NCT03051308
NCT03051308Unknown不适用

University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation: Effects on Calcium Sensing and Vitamin D Receptor During Cold Ischemia

SB Istanbul Education and Research Hospital2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
7
试验地点
2
主要终点
Cell viability of Parathyroid cells after isolation process

研究概览

简要总结

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.

详细描述

Parathormone (PTH) and vitamin D are two critical hormonal regulators of calcium homeostasis. There is an important relationship between the PTH release and vitamin D receptor for controlling hormonal systems. Also calcium-sensing receptor plays a crucial role in regulating parathormone secretion which means controlling the calcium-dependent systemic ion homeostasis.

Cold ischemia protects organs and tissues by slowing their metabolism. The cold ischemia of the transplant tissue is a very important process. The University of Wisconsin (UW) solution substantially improves graft preservation and consequently increases patient survival. The researchers newly developed NPTS for transportation of parathyroid glands.

For the comparision the researchers measured the parathyroid cell viability and the calcium sensing and vitamin D receptor density of the parathyroid cells at the 0, 6, 12 and 24 hours of cold ischemia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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).

结局指标

主要结局

Cell viability of Parathyroid cells after isolation process

时间窗: 0 hour

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.

Cell viability of Parathyroid cells after 12 hour of cold ischemia

时间窗: 12 hour

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.

Cell viability of Parathyroid cells after 18 hour of cold ischemia

时间窗: 18 hour

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.

Cell viability of Parathyroid cells after 6 hour of cold ischemia

时间窗: 6 hour

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.

Cell viability of Parathyroid cells after 24 hour of cold ischemia

时间窗: 24 hour

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.

次要结局

  • Parathormone Release of Parathyroid Cells(1 day)

研究者

发起方
SB Istanbul Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erhan Aysan

Principal Investigator

SB Istanbul Education and Research Hospital

研究点 (2)

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