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临床试验/NCT02717039
NCT02717039招募中不适用

Pharmacogenomics of Heparin-Induced Thrombocytopenia

University of Arizona1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
125
试验地点
1
主要终点
Serotonin Release Assay

研究概览

简要总结

The purpose of this research is to identify genomic markers that can predict heparin-induced thrombocytopenia (HIT), which is a very serious side effect to heparin. Heparin is commonly used to prevent blood clots and the investigators may be able to identify genomic markers which can be used to prevent heparin use in people who will get HIT.

详细描述

Inclusion Criteria: 18 years of age or older; Participants with heparin/PF4 antibody and SRA testing for HIT, including:

participants with negative heparin/PF4 antibodies and negative SRA (controls), participants with positive heparin/PF4 antibodies and negative SRA(seroconversion cases), participants with positive heparin/PF4 antibodies and positive SRA (HIT cases); Treatment with unfractionated heparin or low molecular weight heparin (enoxaparin, dalteparin, tinzaparin) within 7 days of blood draw Exclusion Criteria: Less than 18 years of age; Inability to give informed consent There is no randomization involved in this study. Participants will be enrolled in equal numbers from three categories: (1) participants without HIT testing negative for heparin/PF4 antibodies (controls); (2) participants without HIT testing positive for heparin/PF4 antibodies (seroconversion cases); (3) participants with HIT testing positive for both heparin/PF4 antibodies (HIT cases).

Recruitment will be facilitated through collaborators in the Coagulation Laboratory and through key study personnel in the Banner Univerisyt Medical Center - Tucson. Patients with positive and negative heparin/PF4 antibody and serotonin release assay results will be identified in the Coagulation Laboratory and the patient's provider will be approached about potential participation in research studies. If the potential participant is interested, they will be approached by study personnel for study description and possible consent. Alternatively, clinical collaborators who are consulted and participating directly in a patients care may contact a potential participant directly for willingness to participate in the study.

Patients consenting to the study will be asked to provide a one blood sample of approximately 150 milliliters. Peripheral blood mononuclear cells (PBMCs) will be isolated from this sample and stored at -80C before use in proposed experiments. Genomic DNA will also be isolated from the sample to perform HLA sequencing.

HIT will be confirmed with a functional serotonin release assay and HIT likelihood based on clinical course. Detailed data will be collected regarding participant's hospitalization, heparin dose and duration, platelet counts, surgical history, and co-morbidities. After consent of participants, a peripheral blood sample will be acquired, CD positive T cells sorted using flow cytometry, and genomic DNA isolated as previously described.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • 18 years of age or older
  • Ability to give informed consent
  • Have undergone testing for heparin/PF4 antibody with or without SRA testing for HIT
  • Have received treatment with unfractionated heparin or low molecular weight heparin (enoxaparin, dalteparin, tinzaparin) prior to antibody or SRA testing

排除标准

  • Less than 18 years of age
  • Pregnancy
  • Hemoglobin less than 9 mg/dL (for larger 5 ounce blood draw)
  • Known Human Immunodeficiency Virus (HIV) infection
  • Inability to give informed consent

结局指标

主要结局

Serotonin Release Assay

时间窗: 0-30 days

Functional assay confirming presence of heparin-induced thrombocytopenia

Heparin/platelet factor 4 antibody

时间窗: 0-30 days

ELISA for confirming presence of heparin/PF4 antibodies necessary for HIT

次要结局

未报告次要终点

研究者

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

Jason H Karnes

Assistant Professor

University of Arizona

研究点 (1)

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