Measurement of Blood Parameter EquivalencyNCT06415058
Study to Investigate Blood Samples Drawn With the HemoIV System
An observational study of Measurement of Blood Parameter Equivalency, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Measurement of Blood Parameter Equivalency
- What is being tested?
- HemoIV
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2024to 21 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Being tested
- HemoIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoIVDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HemoIV Blood Sampling | Measurement of protocol specified blood parameters drawn from the HemoIV system Receives: Device: HemoIV | |
| Control Blood Sampling | Measurement of protocol specified blood parameters drawn from the contralateral control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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%
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Secondary outcomes (6)
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."
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start2 May 2024
- Primary completion18 Feb 2025
- Study completion21 Feb 2025
Why it stopped: Enrollment limitation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Measurement of Blood Parameter EquivalencyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- MedTG LLC
- Responsible party
- Principal investigator, Brian Bales, Vanderbilt University Medical Center
- Investigators
- Sean Collins, MD, MSCi, Study director, Vanderbilt University Medical CenterBrian Bales, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415058
- Sponsor's protocol ID
- HemoIV
- Status last verified
- Jun 2025
- First submitted
- 1 May 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Nonrandomized Controlled Clinical Investigation of Blood Samples Drawn With the HEMOIV System During Continuous IV Flow
- ClinicalTrials.gov ID
- NCT06415058
- Acronym / sponsor ID
- HemoIV
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment limitation
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- MedTG LLC
- Study start
- 2 May 2024 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HemoIV Blood Sampling | – | Device: HemoIVMeasurement of protocol specified blood parameters drawn from the HemoIV system |
| Control Blood Sampling | – | –Measurement of protocol specified blood parameters drawn from the contralateral control arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemoIVA 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. | Device | HemoIV Blood Sampling |
Primary outcome
Measurement of Whole Blood Count (WBC) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
White Blood Cell Count (WBC) Min: 3.9 to Max:10.7 (10 to the power of 3/uL)
Measurement of Red Blood Count (RBC) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Red Blood Cell Count (RBC) Min: 4.0 to Max: 6.0 (10 to the power of 6/uL)
Measurement of Hemoglobin (HGB) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Hemoglobin (HGB) Min: 11.8 to Max: 18.1 g/dl
Measurement of Hematocrit (HCT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Hematocrit (HCT) Min: 36% to Max: 49%
Measurement of Platelets (PLT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Platelets (PLT) Min: 135 to Max: 371 (10 to the power of 3/uL)
Measurement of Albumin (ALB) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Albumin (ALB) Min: 3.2 to Max: 5.2 g/dL
Measurement of Alkaline Phosphatase (AKP) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Alkaline Phosphatase (AKP) Min: 40 to Max: 164 u/L
Measurement of Total Bilirubin (T BILI) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Total Bilirubin (T BILI) Min: 0.1 to Max: 1.2 mg/dL
Measurement of Bicarbonate (CO2) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Bicarbonate (CO2) Min: 17 to Max: 31 mmol/L
Measurement of Blood Urea Nitrogen (BUN) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Blood Urea Nitrogen (BUN) Min: 7 to Max: 26 mg/dL
Measurement of Calcium (CA) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Calcium (CA) Min: 8.4 to Max: 10.5 mg/dL
Measurement of Chloride (CL) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Chloride (CL) Min: 98 to Max: 107 mmol/L
Measurement of Creatinine (Cr) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Creatinine (Cr) Min: 0.57 to Max: 1.25 mg/dL
Measurement of Glucose (Glu) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Glucose (Glu) Min: 70 to Max: 99 mg/dL
Measurement of Potassium (K) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Potassium (K) Min: 3.3 to Max: 4.8 mmol/L
Measurement of Total Protein (TP) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Total Protein (TP) Min: 6.0 to Max: 8.3 g/dL
Measurement of Aspartate Aminotransferase (AST) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Aspartate Aminotransferase (AST) Min: 5 to Max: 35 u/L
Measurement of Alanine Transaminase (ALT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Alanine Transaminase (ALT) Min: 0 to Max: 55 u/L
Measurement of Sodium (NA) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Sodium (NA) Min: 136 to Max: 145 mmol/L
Measurement of Lactate Dehydrogenase (LDH) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Lactate Dehydrogenase (LDH) Min: 125 to Max: 250 u/L
Measurement of International normalized ratio (INR)/ Prothrombin Time (PT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
International normalized ratio (INR)/ Prothrombin Time (PT) Min: 11.7 to Max: 14.5 seconds
Measurement of Partial Thromboplastin Time (PTT) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Partial Thromboplastin Time (PTT) Min: 23.5 to Max: 35.5 seconds
Measurement of Fibrinogen parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Fibrinogen Min: 220 to Max: 415 mg/dL
Measurement of Total Cholesterol (CHOL) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Total Cholesterol (CHOL) Min: 0 to Max: 199 mg/dL
Measurement of Triglycerides (TRIG) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Triglycerides (TRIG) Min: 0 to Max: 149 mg/dL
Measurement of High Density Lipoprotein (HDL) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
High Density Lipoprotein (HDL) Min: 0 to Max: 100 mg/dL
Measurement of Low Density Lipoprotein (LDL) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Low Density Lipoprotein (LDL) Min: 0 to Max: 300 mg/dL
Measurement of Troponin I parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Troponin I Min: 0.00 to Max: 0.03 ng/mL
Measurement of Natriuretic Peptides (BNP) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Natriuretic Peptides (BNP) Min: 10 to Max: 100 pg/mL
Measurement of C-Reactive Protein (CRP) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
C-Reactive Protein (CRP) Min: 0 to Max: 5 mg/dL
Measurement of Erythrocyte Sedimentation Rate (ESR) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Erythrocyte Sedimentation Rate (ESR) Min: 1 to Max: 37 mm/hr
Measurement of Human chorionic gonadotropin (HCG) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques.
Time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)
Human chorionic gonadotropin (HCG) Min: 0 to Max: 5 mIU/mL
6 secondary outcomes
Wong-Baker Faces Pain Rating Scale.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Timepoint 0 hour (at time of device insertion) and 8-22 hours (post device insertion)
Results and safety
The study was stopped early (reason given: Enrollment limitation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Collins, MD, MSCi study director
Vanderbilt University Medical Center
Brian Bales, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Measurement of Blood Parameter Equivalency, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment limitation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Whole Blood Count (WBC) parameter equivalency with HemoIV to the control arm standard of care phlebotomy techniques. (time frame: Time point 0 hour (at time of device insertion) and 8-22 hour (post device insertion)). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.