A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
2020年11月17日 更新者：Rockwell Medical Technologies, Inc.
A Randomized 3 Period Crossover Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
This study will investigate the effect of co-administration of Triferic and heparin on the ability to maintain circuit anti-coagulation and iron delivery when compared to control conditions when each treatment is administered via separate routes.
研究概览
研究类型
介入性
注册 (实际的)
12
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Florida
-
Orlando、Florida、美国、32809
- Orlando Clinical Research Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adult hemodialysis patients ≥18 years of age.
- Signed informed consent to participate in the study.
- Stable on hemodialysis prescription for ≥3 months.
- Hemoglobin concentration >9.5 g/dL.
- Serum TSAT ≥20%.
- Able to receive continuous heparin infusion as their anticoagulation protocol.
- Receiving hemodialysis via AV (arteriovenous) fistula or graft.
- Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.
Exclusion Criteria:
- Active bleeding disorder (GI, skin, nasal…)
- Receiving hemodialysis via catheter.
- Receiving heparin free dialysis.
- Receiving low molecular weight heparin as sole anti-coagulation for dialysis.
- Receiving IV iron within 2 weeks of the first on-study hemodialysis treatment.
- Receiving oral anti-coagulants or anti-platelet agents.
- Any other condition, that in the opinion of the investigator would not allow completion of the 3 hemodialysis treatments in the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Triferic post-dialyzer; UFH via continuous infusion
Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump.
Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump.
The infusion of heparin to be stopped at hour 3 of hemodialysis.
|
Triferic（柠檬酸焦磷酸铁，FPC）是一种铁替代产品，是一种铁络合物，其中铁 (III) 与焦磷酸盐和柠檬酸盐结合。
其他名称：
Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
其他名称：
|
|
实验性的：UFH and Triferic admixture
Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line".
This mixture will be administered by the on-machine syringe infusion pump for continuous infusion.
Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin.
The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis.
|
Triferic（柠檬酸焦磷酸铁，FPC）是一种铁替代产品，是一种铁络合物，其中铁 (III) 与焦磷酸盐和柠檬酸盐结合。
其他名称：
Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
其他名称：
|
|
实验性的：UFH via continuous infusion pre-dialyzer
Patients will receive no Triferic.
Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump.
The infusion of heparin to be stopped at hour 3 of hemodialysis
|
Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t
大体时间：8 hours
|
8 hours
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours
大体时间：4 hours
|
4 hours
|
|
aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
大体时间：4 hours
|
4 hours
|
|
TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
大体时间：4 hours
|
4 hours
|
|
Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)
大体时间：8 hours
|
8 hours
|
|
Iron Profile as Measured by the AUC (Area Under the Curve) 0-t
大体时间：8 hours
|
8 hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Raymond Pratt, MD、Rockwell Medical
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年9月30日
初级完成 (实际的)
2020年1月16日
研究完成 (实际的)
2020年1月16日
研究注册日期
首次提交
2019年7月22日
首先提交符合 QC 标准的
2019年7月31日
首次发布 (实际的)
2019年8月1日
研究记录更新
最后更新发布 (实际的)
2020年12月2日
上次提交的符合 QC 标准的更新
2020年11月17日
最后验证
2020年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.