跳至主要内容
临床试验/NCT01318707
NCT01318707已完成不适用

Biomarkers Serum Collection Methodology Pilot Study

Georgetown University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1

研究概览

简要总结

The purpose of this study is to compare the standard collection of whole blood in tiger top tubes for serum collection versus a collection method of added FVIII to whole blood samples in the hemophilia population for routine biomarker assays to ensure reliable assay results.

详细描述

20 adults with severe Hemophilia A seen in one HTC site for routine blood drawing will be consented for discard blood sampling.

Half of the whole blood discard will be placed in a tiger top test tube, and half of the whole blood discard sample will be placed in a red top test tube containing exogenously added recombinant human FVIII concentrate [Advate, Baxter immuno] to assure an end concentration of once IU per CC of whole blood.

Both whole blood specimens will be allowed to coagulate at room temperature and then will be centrifuged to prepare serum. The separated serum from each type of collection test tubes will be aliquoted into eppendorf tubes (a minimum of two aliquots per sample) at a volume of 150 microliters. Aliquoted serum samples will be stored at -70 degrees centigrade and shipped on dry ice to Synarc Labs.

A panel of standard CTX bone resorption assays will be preformed in duplicate on the two differently processed serum specimens obtained from each subject.

Results will be analyzed for inter-subject variability using stored age-matched samples provided by Synarc and intra-subject variability will also be analyzed.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Severe Hemophilia A

排除标准

  • If they are not diagnosed with severe hemophilia A.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Craig Kessler

IRB

Georgetown University

研究点 (1)

Loading locations...

相似试验