The Role of Plasminogen Activator Inhibitor-1 (PAI-1), Tissue Plasminogen Activator (tPA), Tissue Factor Pathway Inhibitor (TFPI), and Endometrial Endothelial Cells in Uterine Hemostasis in Humans
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Total number of mRNA copies from HEEC culture of tPA
研究概览
简要总结
The purpose of the study is to learn more about the role of blood clotting factor proteins and cells in menstrual (period) bleeding. The investigators are hoping to identify differences in these proteins and cells in the menstrual blood of individuals with heavy periods compared to menstruating individuals who do not have heavy periods.
详细描述
The purpose of this study is to learn if human endometrial endothelial cells (HEECs) regulate human uterine hemostasis through the up and down-regulation of pro- and anti-coagulant factors in menstrual blood including PAI-1, factor XI (FXI)-PAI-1 complex, tPA, and TFPI.
This study will enroll participants with heavy menstrual bleeding (HMB) and participants without HMB. Coagulation factors will be measured in menstrual blood and mRNA for these factors will be quantified from cultured HEECS from endometrial biopsies and compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Regularly menstruating participants between 18-45 years of age
排除标准
- •Pregnancy within 3 months of enrollment
- •Lactating at the time of enrollment
- •Hormonal contraceptive use or use of the copper intrauterine device (IUD)
- •Antifibrinolytic use
- •Inherited or acquired bleeding disorder or anticoagulant use
- •Known structural cause of HMB
- •Inability to complete PBACs
- •Unwilling to refrain from sexual intercourse for the two weeks prior to endometrial biopsy
结局指标
主要结局
Total number of mRNA copies from HEEC culture of tPA
时间窗: Enrollment to 60 days
The total number of mRNA copies of tPA in HEEC cultures from enrollment to 60 days.
Total number of mRNA copies from HEEC culture of PAI-1
时间窗: Enrollment to 60 days
The total number of mRNA copies of PAI-1 in HEEC cultures from enrollment to 60 days.
Total number of mRNA copies from HEEC culture of TFPI
时间窗: Enrollment to 60 days
The total number of mRNA copies of TFPI in HEEC cultures from enrollment to 60 days.
Change in the numerical score of Pictorial Blood Loss Assessment
时间窗: Enrollment to 60 days
The change in the Pictorial Blood Loss Assessment Charts (PBACs) from baseline to 60 days. Participants will be asked to tally the number of pads and tampons, the level of saturation of menstrual blood on the pads or tampons, and the number of clots. Scores greater than 100 are considered diagnostic of heavy menstrual bleeding.
次要结局
未报告次要终点
研究者
Bannowb
Principal Investigator
Oregon Health and Science University