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临床试验/NCT02814799
NCT02814799Unknown不适用

Study of the Effects of the Bone Tissue on the Generation of Thrombine

CHU de Reims1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
CHU de Reims
入组人数
30
试验地点
1
主要终点
thrombin quantification

研究概览

简要总结

The research for a haemostasis and for an effective osseous healing are a major stake in oral surgery. The use of glues of fibrin, amplifying the polymerization of the fibrin during the haemostasis is known to reduce the risk of post-operative bruise and accelerate the healing but these glues present the inconvenience to be by-products of the blood, not devoid of infectious risk.

详细描述

Thrombinography is a functional exploration of the haemostasis allowing the characterization of the kinetics and the amount of thrombin. Its principle bases on the recording of the activity of the in vitro thrombin, by fluorometry. The formed thrombin leads a signal by activation of the fluorogenic substrates. The intensity of the received signal is correlated in the generation of thrombin by comparative measure of the fluorescence of a standard sample of thrombinic activity known. The analysis is realized by a specific software: Thrombinoscope®. The used reactional environment is a poor Plasma in platelet (PPP).

The software defines the quantity of thrombin generated (nM) according to time (in minute) and calculate the values of:

  • Lag time: latent period before the beginning of synthesis of thrombin.
  • Start Tail: duration of the process.
  • Peak: peak of thrombin, is the maximal rate of generated thrombin.
  • ETP (Endogenous Thrombin Potential): area under the curve representing the total potential of generation of thrombin.
  • Time to Peak: time required to reach the peak of thrombin. It is these values which will serve as criteria of evaluation for our study.

Osseous type

The cancellous bone is majority in the short bones and the epiphyses of the long bones. It is crisp, constituted by fine osseous patches arranged in a not concentric way around wide open cavities, filled with bone marrow rich in cells, and richly vascularized. The cancellous bone is surrounded with compact bone. At the level of tooth sockets, this osseous type is found in particular at the level of interradicular septa.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

thrombin quantification

时间窗: Day 1

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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