Comparative Effectiveness of Heparin Versus Normal Saline in Maintaining Patency of Peripherally Inserted Central Catheter Lines in Oncology Inpatients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Patency
研究概览
简要总结
The study team will be performing a study comparing the use of Heparin Flushes vs. Normal Saline Flushes in making sure central lines stay open. The participants will be placed in a group to receive the University of Texas Southwestern Medical Center (UTSW) Standard of Care (control group) for maintaining central lines, or a group to receive Normal Saline Flushes only (experimental group) to keep their central line open. The participants electronic medical record will be reviewed by study team members for the inclusion/exclusion criteria, the participants central line will be assessed by an 11 Blue BMT nurse every 12 hours, and they may be asked questions regarding their medical history during their stay on 11 Blue BMT. If a participant is discharged or transferred off of the 11 Blue BMT unit, they will no longer be included in the study and their central line maintenance will return to the UTSW Standard of Care. Participants in this study may be at risk for central line occlusion (a blood clot) which could require intervention to regain the free flow of fluids and use of the central line. The study team predicts there will be no increase in the rate of line occlusion when using Normal Saline Flushes only to maintain the free flow of fluids through participants central line. The study team also hopes the results of this study will help to improve patient outcomes by decreasing risk of infection, heparin associated complications, and costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Oncology patients
- •Admitted to 11Blue Bone Marrow Transplant Unit at Clements University Hospital University of Texas Southwestern Medical Center
- •Ages 18-80 years
- •Pre-existing or newly placed PICC line
- •PICC line with good blood return (defined as: "brisk blood return of 3cc")
- •Flushes without difficulty
排除标准
- •Patient less than 18 years of age or greater than 80 years of age
- •Refused or unable to give consent to the study
- •Patient admitted to the 11Blue BMT unit with any line other than a PICC line, or multiple lines
- •Patient admitted to 11Blue BMT for active transplant
- •Patient with a coagulopathy diagnosis
- •Patient on therapeutic dose of anticoagulants for documented Deep Vein Thrombosis or Pulmonary Embolism
- •Patient on inpatient hospice/comfort care
- •Patient transferred off 11B BMT unit onto another floor
研究组 & 干预措施
Heparin Group
Participants will receive the UTSW standard of of care for PICC line maintenance.
All lumens of PICC line will be flushed w/ Heparin Flush every 8 hours. PICC line will be flushed with 10cc Normal Saline followed by 3cc Heparin Flush after administration of medication, blood products, or blood draws.
干预措施: Heparin Group (Drug)
Normal Saline Group
Participants will receive only Normal Saline for PICC line maintenance. All lumens of PICC line will be flushed every 24 hours with 10cc Normal Saline. PICC line will be flushed with 10cc Normal Saline after administration of medication, blood products, or blood draws.
干预措施: Normal Saline Group (Drug)
结局指标
主要结局
Patency
时间窗: Up to Day 7 of enrollment
To determine whether or not flushing central lines with normal saline only will maintain free flow through these central lines.
次要结局
- Infection Rate(From Day 1 and up to Day 7 of enrollment)
研究者
Meredith Allen
Registered Nurse
University of Texas Southwestern Medical Center