AnemiaNCT03286465
Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions
A study testing Pediatric phlebotomy tubes and Adult phlebotomy tubes in people with Anemia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study will evaluate the hypothesis that the use of pediatric size phlebotomy tubes reduces red blood cell (RBC) transfusions in adult intensive care unit (ICU) patients compared with the use of adult size tubes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Pediatric phlebotomy tubes and Adult phlebotomy tubes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New admission to the medical or transplant ICU at Memorial Hermann Hospital in Houston
- ICU admission hemoglobin level of at least 7 g/dL. The ICU admission hemoglobin will be the most recent hemoglobin value available at the time of screening for inclusion in the study.
- Randomization is expected within 12 hour of admission to the ICU
Who cannot join
- Clinical bleeding. Defined as menstrual bleeding, bleeding leading to a change in the frequency of hemoglobin monitoring or to an order for a medication, transfusion, procedure, or consultation intended to prevent or treat bleeding.
- Known hemolytic disorder (e.g. sickle cell disease, hereditary spherocytosis, autoimmune hemolytic anemia)
- Bone marrow disorder (e.g. aplastic anemia, marrow infiltration disorder, chemotherapy within the last 8 weeks)
- Jehovah's Witnesses
- Patient is comfort care measures only
- Refractory shock: mean arterial blood pressure below 60 mmHg despite maximal doses of 3 vasopressors. Maximal dose of vasopressors are as follows: Norepinephrine 70 mcg/min; vasopressin 0.04 units/min; epinephrine 35 mcg/min; dopamine 20 mcg/kg/min; phenylephrine 350 mcg/min
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- Severe acidosis: potential of hydrogen (pH) below 7 in more than one arterial blood gas within 24 hours of ICU admission in the absence of diabetic ketoacidosis Surgical admission diagnosis
- Pregnancy
- Current prisoner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot, Randomized Trial of the Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions
This study will evaluate the hypothesis that the use of pediatric size phlebotomy tubes reduces red blood cell (RBC) transfusions in adult intensive care unit (ICU) patients compared with the use of adult size tubes.
- Conditions
- Anemia
- Being tested
- Pediatric phlebotomy tubes, Adult phlebotomy tubes
- Keywords
- blood transfusion
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric phlebotomy tubesDevice
Use of pediatric size tubes for diagnostic blood collection.
Adult phlebotomy tubesDevice
Use of adult size tubes for diagnostic blood collection.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric phlebotomy tubes | Experimental | Use of pediatric size tubes for diagnostic blood collection. Receives: Device: Pediatric phlebotomy tubes |
| Adult phlebotomy tubes | Active comparator | Use of adult size tubes for diagnostic blood collection. Receives: Device: Adult phlebotomy tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order
Measured: from time of admission to intensive care unit (ICU) to 30 days after admission to ICU
Secondary outcomes (5)
Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)
This will be calculated as the most recent hemoglobin prior to randomization minus the last hemoglobin prior to ICU discharge, death, RBC transfusion, clinical bleeding, surgery, or change of clinical status to comfort measures, divided by the number of days (rounded to the nearest 0.5) between these two values (crude estimate).
Measured: from time of randomization to completion of study (up to 30 days after ICU admission)
Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU
Measured: completion of study (up to 30 days after ICU admission)
Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis
An inadequate blood sample is defined as any blood sample that requires recollection.
Measured: completion of study (up to 30 days after ICU admission)
ICU Mortality
Measured: completion of study (up to 30 days after ICU admission)
Total Phlebotomy Volume
The total phlebotomy volume is the total volume of blood collected over all days and is estimated based on the maximum volume needed for each type of blood test, as follows. In the pediatric tube arm, the volumes were 0.5 milliliters (mL) for hematology, 0.6 mL for chemistries (plasma), and 2.5 mL for coagulation tests. In the adult tube group, the volumes were 5.5 mL for hematology, 5 mL for chemistries (plasma), and 3.8 mL for coagulation. In both arms, tube volumes for lactate, immunology (serum), arterial blood gases, and blood cultures were 5 mL, 6.5 mL, 1 mL, and 10 mL, respectively.
Measured: completion of study (up to 30 days after ICU admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start7 Nov 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Barreda Garcia, The University of Texas Health Science Center, Houston
- Investigators
- Javier Barreda Garcia, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286465
- Sponsor's protocol ID
- HSC-MS-17-0280
- Status last verified
- Aug 2021
- First submitted
- 14 Sep 2017
- Last updated
- 30 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Barreda Garcia J, Xian JZ, Pedroza C, Salahuddin M, Mak G, Keene A, Cherian SV, Young AY, Vijhani P, Doshi PB. Pediatric size phlebotomy tubes and transfusions in adult critically ill patients: a pilot randomized controlled trial. Pilot Feasibility Stud. 2020 Aug 8;6:112. doi: 10.1186/s40814-020-00657-3. eCollection 2020.
PubMed 32782818
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Randomized Trial of the Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions
- ClinicalTrials.gov ID
- NCT03286465
- Acronym / sponsor ID
- HSC-MS-17-0280
- Conditions
- Anemia
- Keywords
- blood transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Posted 30 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the hypothesis that the use of pediatric size phlebotomy tubes reduces red blood cell (RBC) transfusions in adult intensive care unit (ICU) patients compared with the use of adult size tubes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric phlebotomy tubes | Experimental | Device: Pediatric phlebotomy tubesUse of pediatric size tubes for diagnostic blood collection. |
| Adult phlebotomy tubes | Active comparator | Device: Adult phlebotomy tubesUse of adult size tubes for diagnostic blood collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- New admission to the medical or transplant ICU at Memorial Hermann Hospital in Houston
- ICU admission hemoglobin level of at least 7 g/dL. The ICU admission hemoglobin will be the most recent hemoglobin value available at the time of screening for inclusion in the study.
- Randomization is expected within 12 hour of admission to the ICU
Key exclusion criteria (9 listed)
- Clinical bleeding. Defined as menstrual bleeding, bleeding leading to a change in the frequency of hemoglobin monitoring or to an order for a medication, transfusion, procedure, or consultation intended to prevent or treat bleeding.
- Known hemolytic disorder (e.g. sickle cell disease, hereditary spherocytosis, autoimmune hemolytic anemia)
- Bone marrow disorder (e.g. aplastic anemia, marrow infiltration disorder, chemotherapy within the last 8 weeks)
- Jehovah's Witnesses
- Patient is comfort care measures only
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 |
|---|---|---|
| Pediatric phlebotomy tubesUse of pediatric size tubes for diagnostic blood collection. | Device | Pediatric phlebotomy tubes |
| Adult phlebotomy tubesUse of adult size tubes for diagnostic blood collection. | Device | Adult phlebotomy tubes |
Primary outcome
Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order
Time frame: from time of admission to intensive care unit (ICU) to 30 days after admission to ICU
5 secondary outcomes
Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)
Time frame: from time of randomization to completion of study (up to 30 days after ICU admission)
Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU
Time frame: completion of study (up to 30 days after ICU admission)
Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis
Time frame: completion of study (up to 30 days after ICU admission)
ICU Mortality
Time frame: completion of study (up to 30 days after ICU admission)
Total Phlebotomy Volume
Time frame: completion of study (up to 30 days after ICU admission)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32782818Barreda Garcia J, Xian JZ, Pedroza C, Salahuddin M, Mak G, Keene A, Cherian SV, Young AY, Vijhani P, Doshi PB. Pediatric size phlebotomy tubes and transfusions in adult critically ill patients: a pilot randomized controlled trial. Pilot Feasibility Stud. 2020 Aug 8;6:112. doi: 10.1186/s40814-020-00657-3. eCollection 2020.
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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.
Javier Barreda Garcia, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric phlebotomy tubes and Adult phlebotomy tubes in people with Anemia, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 30 Aug 2021. 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?
Yes. Results are posted in the registry (first posted 30 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order (time frame: from time of admission to intensive care unit (ICU) to 30 days after admission to ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03286465, which also lists 1 linked publication.
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 30 Aug 2021.