Study to Investigate Blood Samples Drawn With the HemoIV System

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Measurement of Blood Parameter Equivalency
• Intervention / Treatment: Device: HemoIV

Detailed Description

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.

Participants will:

• Receive standard of care intravenous therapy via HemoIV inserted through an established peripheral IV catheter
• Have blood samples obtained twice over a 24 hour period from the HemoIV and from an IV line or standard venipuncture from the contralateral arm
• The second blood sampling will occur approximately 8-22 hours after the first blood sampling
• The HemoIV device will be removed one hour after the second blood sampling occurs
• Participants will be called 8 days later to assess for adverse events

Quality control (QC) procedures will be implemented beginning with the data entry system and data QC checks that will be run on the database will be generated. Any missing data or data anomalies will be communicated to the site(s) for clarification/resolution.

• Study Type: Observational
• Enrollment (Estimated): 106

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patient population will be enrolled from those admitted in the hospital (emergency department, inpatient, and observation setting) for a medical condition that require peripheral intravenous catheter fluids and blood draws up to a 24 hour period. Patients receiving Normal Saline, Lactate Ringer, or 5% Dextrose in Water will be enrolled.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HemoIV Blood Sampling; Measurement of protocol specified blood parameters drawn from the HemoIV system	Device: HemoIV; A sterile, single use device. It is a non-patient stick blood collection device that attaches to a peripheral IV catheter (PIV catheter) and allows for blood sample collection to occur during continuous IV infusion therapy. The control blood sampling will occur via standard of care blood draws either through peripheral IV catheter or standard venipuncture.
Control Blood Sampling; Measurement of protocol specified blood parameters drawn from the contralateral control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Whole Blood Count (WBC) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	White Blood Cell Count (WBC) Min: 3.9 to Max:10.7 (10 to the power of 3/uL)	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Red Blood Count (RBC) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Red Blood Cell Count (RBC) Min: 4.0 to Max: 6.0 (10 to the power of 6/uL)	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Hemoglobin (HGB) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Hemoglobin (HGB) Min: 11.8 to Max: 18.1 g/dl	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Hematocrit (HCT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Hematocrit (HCT) Min: 36% to Max: 49%	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Platelets (PLT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Platelets (PLT) Min: 135 to Max: 371 (10 to the power of 3/uL)	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Albumin (ALB) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Albumin (ALB) Min: 3.2 to Max: 5.2 g/dL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Alkaline Phosphatase (AKP) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Alkaline Phosphatase (AKP) Min: 40 to Max: 164 u/L	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Total Bilirubin (T BILI) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Total Bilirubin (T BILI) Min: 0.1 to Max: 1.2 mg/dL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Bicarbonate (CO2) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Bicarbonate (CO2) Min: 17 to Max: 31 mmol/L	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Blood Urea Nitrogen (BUN) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Blood Urea Nitrogen (BUN) Min: 7 to Max: 26 mg/dL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Calcium (CA) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Calcium (CA) Min: 8.4 to Max: 10.5 mg/dL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Chloride (CL) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Chloride (CL) Min: 98 to Max: 107 mmol/L	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Creatinine (Cr) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Creatinine (Cr) Min: 0.57 to Max: 1.25 mg/dL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Glucose (Glu) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Glucose (Glu) Min: 70 to Max: 99 mg/dL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Potassium (K) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Potassium (K) Min: 3.3 to Max: 4.8 mmol/L	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Total Protein (TP) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Total Protein (TP) Min: 6.0 to Max: 8.3 g/dL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Aspartate Aminotransferase (AST) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Aspartate Aminotransferase (AST) Min: 5 to Max: 35 u/L	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Alanine Transaminase (ALT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Alanine Transaminase (ALT) Min: 0 to Max: 55 u/L	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Sodium (NA) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Sodium (NA) Min: 136 to Max: 145 mmol/L	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Lactate Dehydrogenase (LDH) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Lactate Dehydrogenase (LDH) Min: 125 to Max: 250 u/L	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of International normalized ratio (INR)/ Prothrombin Time (PT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	International normalized ratio (INR)/ Prothrombin Time (PT) Min: 11.7 to Max: 14.5 seconds	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Partial Thromboplastin Time (PTT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Partial Thromboplastin Time (PTT) Min: 23.5 to Max: 35.5 seconds	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Fibrinogen parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Fibrinogen Min: 220 to Max: 415 mg/dL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Total Cholesterol (CHOL) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Total Cholesterol (CHOL) Min: 0 to Max: 199 mg/dL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Triglycerides (TRIG) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Triglycerides (TRIG) Min: 0 to Max: 149 mg/dL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of High Density Lipoprotein (HDL) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	High Density Lipoprotein (HDL) Min: 0 to Max: 100 mg/dL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Low Density Lipoprotein (LDL) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Low Density Lipoprotein (LDL) Min: 0 to Max: 300 mg/dL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Troponin I parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Troponin I Min: 0.00 to Max: 0.03 ng/mL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Natriuretic Peptides (BNP) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Natriuretic Peptides (BNP) Min: 10 to Max: 100 pg/mL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of C-Reactive Protein (CRP) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	C-Reactive Protein (CRP) Min: 0 to Max: 5 mg/dL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Erythrocyte Sedimentation Rate (ESR) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Erythrocyte Sedimentation Rate (ESR) Min: 1 to Max: 37 mm/hr	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Measurement of Human chorionic gonadotropin (HCG) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.	Human chorionic gonadotropin (HCG) Min: 0 to Max: 5 mIU/mL	Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wong-Baker Faces Pain Rating Scale.	Wong-Baker Faces Pain Rating Scale is a method for someone to self-assess and effectively communicate the severity of pain they may be experiencing. The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst."	Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion)
Study staff usability evaluation of the insertion of HemoIV device.	Study staff will rate the insertion of the device using a difficulty scale from 1-5. 1=Very Difficult, 2= Difficult, 3=Neutral, 4=Easy, 5=Very Easy	Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion)
Study staff usability evaluation of blood sample collection from the HemoIV device.	Study staff will rate the blood sample collection from the HemoIV device using a difficulty scale from 1-5. 1=Very Difficult, 2= Difficult, 3=Neutral, 4=Easy, 5=Very Easy	Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion)
Study staff usability evaluation of the ease of the IV solution infusion with the HemoIV device.	Study staff will rate the easy of the IV solution infusion with the HemoIV using a difficulty scale from 1-5. 1=Very Difficult, 2= Difficult, 3=Neutral, 4=Easy, 5=Very Easy	Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion)
Study staff usability evaluation of the easy of the clearing of the blood channel with the HemoIV device	Study staff will rate the easy of the clearing of the blood channel with the HemoIV using a difficulty scale from 1-5. 1=Very Difficult, 2= Difficult, 3=Neutral, 4=Easy, 5=Very Easy	Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion)
Study staff usability evaluation of the easy of withdrawal of the HemoIV device	Study staff will rate the easy of withdrawal of the HemoIV using a difficulty scale from 1-5. 1=Very Difficult, 2= Difficult, 3=Neutral, 4=Easy, 5=Very Easy	Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: MedTG LLC
• Investigators: Study Director: Sean Collins, MD, MSCi, Vanderbilt University Medical Center; Principal Investigator: Brian Bales, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HemoIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes