A Prospective, Nonrandomized Controlled Clinical Investigation of Blood Samples Drawn With the HEMOIV System During Continuous IV Flow

Vanderbilt University Medical Center1 个研究点分布在 1 个国家目标入组 19 人开始时间: 2024年5月2日最近更新: 2025年6月12日

适应症

试验速览

阶段: 不适用
状态: 终止
发起方: Vanderbilt University Medical Center
入组人数: 19
试验地点: 1
主要终点: Measurement of Red Blood Count (RBC) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this study is to compare blood drawn using a device called HemoIV to standard-of-care blood drawn from a vein in the arm or from an IV catheter. The HemoIV is a device that is attached to an IV line. This device allows for blood to be drawn while a patient is receiving IV fluids.

The main questions it aims to answer are:

Will the HemoIV device allow blood to be drawn without having to stop IV fluids?
Will the HemoIV device provide the same laboratory results as blood draws done by current standard practice?

Participants will:

Receive standard medical procedures and/or treatment;
Have a HemoIV device inserted into their IV line in one arm;
Have an blood drawn twice from the HemoIV and from an IV line or needle stick from a vein in the other arm. The second blood draw will be done about 8-22 hours after the first blood draw;
Have the device removed after the second blood draw;
Receive a phone call about 8 days later to see how you are doing.

详细描述

The HemoIV investigational device allows for continuous administration of intravenous fluids for blood draw sampling without exposing patients to additional needle sticks, stoppage of intravenous therapy, and potential exposure to bacteria that are inherent risks when performing blood draws using traditional phlebotomy methods. The purpose of this study is to demonstrate the safety and effectiveness of the HemoIV system.

Participants serve as their own control to compare blood measurement parameters. Blood measurements extracted from the participant will be used to compare the control blood sample(s) to the HemoIV blood sample(s). The contralateral arm to the placement of the HemoIV will be the control arm of the study. It is hypothesized that the HemoIV will provide blood samples within the equivalency margin, compared to standard practice (Venipuncture or Peripheral IV Catheter).

The main objectives are:

To quantitatively measure and compare blood samples drawn with the HemoIV system during continuous intravenous infusion to blood samples from the contralateral arm to demonstrate safety and efficacy of the HemoIV system
To quantitatively measure and compare the potential advantages of HemoIV to Venipuncture or Peripheral IV Catheter blood draws

Participant population will consist of adult patients admitted to the hospital for a medical condition in the emergency department, inpatient, or observation units and are requiring blood draws as well as intravenous fluids.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

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

入选标准

•Provision of signed and dated informed consent form
•Stated willingness to comply with all study procedures and availability for the duration of the study
•Male or female, aged 18 and older
•Willing to adhere to the HemoIV intervention regimen
•Patient scheduled for a hospital procedure for medical condition requiring peripheral intravenous catheter placement, intravenous therapy, and blood draw
•Patients to receive intravenous therapy including: Normal Saline, Lactate Ringer, or 5% Dextrose in Water.
•Patient with peripheral intravenous catheter access vein size > 2 mm in diameter or per investigator discretion able to accept an 18G Peripheral Intravenous Catheter.
•Patient must be able to have a peripheral IV catheter in one arm and can have standard venipuncture blood draws from contralateral arm.
•Patient must be able to have an 18G Peripheral Intravenous Catheter inserted for use with the study device up to 1.88" in length.

排除标准

•Do not speak/understand English
•Patients who have a prior history of mastectomy
•Concurrent participation/treatment with another investigational drug or other intervention study.
•Patient with signs and symptoms of thrombophlebitis at the IV site at the time of study enrollment
•Patients receiving chemotherapy, or who have leukemia for example who have fragile formed cellular element
•Patients which are hemodynamically unstable
•Patients requiring blood transfusion via the 18G peripheral IV catheter used with HemoIV
•Patients who are unable to have a peripheral IV catheter on one upper extremity while having the other upper extremity available for blood tests (e.g. subjects must have two arms, not have an AV graft or fistula anticipating dialysis in the near future, etc.)
•Subjects who are not able to have an IV infusion rate adjusted in the HemoIV to between 10-250 mL/hr during blood draws via HemoIV
•Patient with morbid obesity, (BMI > 40)

结局指标

主要结局

Measurement of Red Blood Count (RBC) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.