Trial Outcomes & Findings for Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions (NCT NCT03286465)
NCT ID: NCT03286465
Last Updated: 2021-08-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
from time of admission to intensive care unit (ICU) to 30 days after admission to ICU
Results posted on
2021-08-30
Participant Flow
Participant milestones
| Measure |
Pediatric Phlebotomy Tubes
Use of pediatric size tubes for diagnostic blood collection.
|
Adult Phlebotomy Tubes
Use of adult size tubes for diagnostic blood collection.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions
Baseline characteristics by cohort
| Measure |
Pediatric Phlebotomy Tubes
n=100 Participants
Use of pediatric size tubes for diagnostic blood collection.
|
Adult Phlebotomy Tubes
n=100 Participants
Use of adult size tubes for diagnostic blood collection.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 16.7 • n=99 Participants
|
57 years
STANDARD_DEVIATION 18.5 • n=107 Participants
|
56.2 years
STANDARD_DEVIATION 17.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
36 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
38 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
26 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
100 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Hemoglobin concentration at intensive care unit (ICU) admission
|
11.4 g/dL
STANDARD_DEVIATION 2.4 • n=99 Participants
|
11.1 g/dL
STANDARD_DEVIATION 2.3 • n=107 Participants
|
11.24 g/dL
STANDARD_DEVIATION 2.35 • n=206 Participants
|
|
Time from ICU admission to randomization
|
5.3 hours
n=99 Participants
|
5.7 hours
n=107 Participants
|
5.64 hours
n=206 Participants
|
|
Estimated blood volume
|
4.9 liters
n=99 Participants
|
4.6 liters
n=107 Participants
|
4.77 liters
n=206 Participants
|
|
Number of participants with chronic hemodialysis
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Number of participants with chronic kidney disease but no dialysis
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Number of participants with active malignancy
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Number of participants with recent history of anemia
|
45 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Charlson comorbidity index
|
3.0 score on a scale
n=99 Participants
|
4.0 score on a scale
n=107 Participants
|
3 score on a scale
n=206 Participants
|
|
ICU Admission Diagnosis
Infection
|
55 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
ICU Admission Diagnosis
Acute Cardiovascular Disorder
|
21 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
ICU Admission Diagnosis
Acute renal failure
|
40 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
ICU Admission Diagnosis
Metabolic disorder
|
32 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
ICU Admission Diagnosis
Non-infectious inflammatory disorder
|
19 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
ICU Admission Diagnosis
Other
|
22 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Number of participants who had invasive mechanical ventilation
|
50 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
APACHE II score
|
22.0 score on a scale
n=99 Participants
|
23.0 score on a scale
n=107 Participants
|
22 score on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: from time of admission to intensive care unit (ICU) to 30 days after admission to ICUOutcome measures
| Measure |
Pediatric Phlebotomy Tubes
n=100 Participants
Use of pediatric size tubes for diagnostic blood collection.
|
Adult Phlebotomy Tubes
n=100 Participants
Use of adult size tubes for diagnostic blood collection.
|
|---|---|---|
|
Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order
|
6 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: from time of randomization to completion of study (up to 30 days after ICU admission)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).
Outcome measures
| Measure |
Pediatric Phlebotomy Tubes
n=100 Participants
Use of pediatric size tubes for diagnostic blood collection.
|
Adult Phlebotomy Tubes
n=100 Participants
Use of adult size tubes for diagnostic blood collection.
|
|---|---|---|
|
Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)
|
-0.21 g/dL/day
Interval -0.48 to 0.021
|
-0.2 g/dL/day
Interval -0.54 to 0.038
|
SECONDARY outcome
Timeframe: completion of study (up to 30 days after ICU admission)Outcome measures
| Measure |
Pediatric Phlebotomy Tubes
n=100 Participants
Use of pediatric size tubes for diagnostic blood collection.
|
Adult Phlebotomy Tubes
n=100 Participants
Use of adult size tubes for diagnostic blood collection.
|
|---|---|---|
|
Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: completion of study (up to 30 days after ICU admission)Population: This outcome data was not collected in the arm using adult phlebotomy tubes.
An inadequate blood sample is defined as any blood sample that requires recollection.
Outcome measures
| Measure |
Pediatric Phlebotomy Tubes
n=100 Participants
Use of pediatric size tubes for diagnostic blood collection.
|
Adult Phlebotomy Tubes
Use of adult size tubes for diagnostic blood collection.
|
|---|---|---|
|
Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: completion of study (up to 30 days after ICU admission)Outcome measures
| Measure |
Pediatric Phlebotomy Tubes
n=100 Participants
Use of pediatric size tubes for diagnostic blood collection.
|
Adult Phlebotomy Tubes
n=100 Participants
Use of adult size tubes for diagnostic blood collection.
|
|---|---|---|
|
ICU Mortality
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: completion of study (up to 30 days after ICU admission)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.
Outcome measures
| Measure |
Pediatric Phlebotomy Tubes
n=100 Participants
Use of pediatric size tubes for diagnostic blood collection.
|
Adult Phlebotomy Tubes
n=100 Participants
Use of adult size tubes for diagnostic blood collection.
|
|---|---|---|
|
Total Phlebotomy Volume
|
21 mL
Interval 7.0 to 38.0
|
50 mL
Interval 27.0 to 100.0
|
Adverse Events
Pediatric Phlebotomy Tubes
Serious events: 9 serious events
Other events: 0 other events
Deaths: 9 deaths
Adult Phlebotomy Tubes
Serious events: 10 serious events
Other events: 0 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Pediatric Phlebotomy Tubes
n=100 participants at risk
Use of pediatric size tubes for diagnostic blood collection.
|
Adult Phlebotomy Tubes
n=100 participants at risk
Use of adult size tubes for diagnostic blood collection.
|
|---|---|---|
|
General disorders
death
|
9.0%
9/100 • Number of events 9 • time of randomization to completion of study (up to 30 days after ICU admission)
Systematically assessed for RBC transfusion-related adverse events.
|
10.0%
10/100 • Number of events 10 • time of randomization to completion of study (up to 30 days after ICU admission)
Systematically assessed for RBC transfusion-related adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Javier Barreda Garcia, MD
The University of Texas Health Science Center at Houston
Phone: 713-500-6838
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place