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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric phlebotomy tubes | Experimental | Use of pediatric size tubes for diagnostic blood collection. |
|
| Adult phlebotomy tubes | Active Comparator | Use of adult size tubes for diagnostic blood collection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pediatric phlebotomy tubes | Device | Use of pediatric size tubes for diagnostic blood collection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order | from time of admission to intensive care unit (ICU) to 30 days after admission to ICU |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Barreda Garcia, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32782818 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pediatric Phlebotomy Tubes | Use of pediatric size tubes for diagnostic blood collection. |
| FG001 | Adult Phlebotomy Tubes | Use of adult size tubes for diagnostic blood collection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pediatric Phlebotomy Tubes | Use of pediatric size tubes for diagnostic blood collection. |
| BG001 | Adult Phlebotomy Tubes | Use of adult size tubes for diagnostic blood collection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order | Posted | Count of Participants | Participants | from time of admission to intensive care unit (ICU) to 30 days after admission to ICU |
|
|
time of randomization to completion of study (up to 30 days after ICU admission)
Systematically assessed for RBC transfusion-related adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pediatric Phlebotomy Tubes | Use of pediatric size tubes for diagnostic blood collection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Javier Barreda Garcia, MD | The University of Texas Health Science Center at Houston | 713-500-6838 | Javier.BarredaGarcia@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2017 | Jan 14, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Adult phlebotomy tubes | Device | Use of adult size tubes for diagnostic blood collection. |
|
| 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 | 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. | completion of study (up to 30 days after ICU admission) |
| ICU Mortality | 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. | completion of study (up to 30 days after ICU admission) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hemoglobin concentration at intensive care unit (ICU) admission | Mean | Standard Deviation | g/dL |
|
| Time from ICU admission to randomization | Median | Inter-Quartile Range | hours |
|
| Estimated blood volume | Median | Inter-Quartile Range | liters |
|
| Number of participants with chronic hemodialysis | Count of Participants | Participants |
|
| Number of participants with chronic kidney disease but no dialysis | Count of Participants | Participants |
|
| Number of participants with active malignancy | Count of Participants | Participants |
|
| Number of participants with recent history of anemia | Count of Participants | Participants |
|
| Charlson comorbidity index | The Charlson comorbidity index predicts 10-year survival in patients with multiple comorbidities. Total score rantes from 0 to 33. The higher the score, the higher the chance of mortality. | Median | Inter-Quartile Range | score on a scale |
|
| ICU Admission Diagnosis | Count of Participants | Participants |
|
| Number of participants who had invasive mechanical ventilation | Count of Participants | Participants |
|
| APACHE II score | The APACHE II score estimates ICU mortality. Total score ranges from 0 to 71 points, with higher scores indicating greater mortality. | Median | Inter-Quartile Range | score on a scale |
|
| Participants |
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | g/dL/day | from time of randomization to completion of study (up to 30 days after ICU admission) |
|
|
|
| Secondary | Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU | Posted | Count of Participants | Participants | completion of study (up to 30 days after ICU admission) |
|
|
|
| Secondary | 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. | This outcome data was not collected in the arm using adult phlebotomy tubes. | Posted | Count of Participants | Participants | completion of study (up to 30 days after ICU admission) |
|
|
|
| Secondary | ICU Mortality | Posted | Count of Participants | Participants | completion of study (up to 30 days after ICU admission) |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | mL | completion of study (up to 30 days after ICU admission) |
|
|
|
| 9 |
| 100 |
| 9 |
| 100 |
| 0 |
| 100 |
| EG001 | Adult Phlebotomy Tubes | Use of adult size tubes for diagnostic blood collection. | 10 | 100 | 10 | 100 | 0 | 100 |
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