Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT03286465
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.7
• Patients Per Site Per Month: 18.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anemia	Device: Pediatric phlebotomy tubes; Device: Adult phlebotomy tubes	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Pilot, Randomized Trial of the Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions
• Actual Study Start Date: Nov 7, 2017
• Actual Primary Completion Date: Sep 30, 2018
• Actual Study Completion Date: Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pediatric phlebotomy tubes Use of pediatric size tubes for diagnostic blood collection.	Device: Pediatric phlebotomy tubes; Use of pediatric size tubes for diagnostic blood collection.
Active Comparator: Adult phlebotomy tubes Use of adult size tubes for diagnostic blood collection.	Device: Adult phlebotomy tubes; Use of adult size tubes for diagnostic blood collection.

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU) [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).

2. 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)]

3. Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis [completion of study (up to 30 days after ICU admission)]

   An inadequate blood sample is defined as any blood sample that requires recollection.

4. ICU Mortality [completion of study (up to 30 days after ICU admission)]

5. Total Phlebotomy Volume [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Hermann Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Javier Barreda Garcia, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 28, 2017

More Information

Publications

None provided.

• Responsible Party: Javier Barreda Garcia, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03286465
• Other Study ID Numbers: HSC-MS-17-0280
• First Posted: Sep 18, 2017
• Last Update Posted: Aug 30, 2021
• Last Verified: Aug 1, 2021

• 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.: No
• Keywords provided by Javier Barreda Garcia, Assistant Professor, The University of Texas Health Science Center, Houston: blood transfusion
• Additional relevant MeSH terms: Critical Illness

Study Results

Participant Flow

Arm/Group Title	Pediatric Phlebotomy Tubes	Adult Phlebotomy Tubes
Arm/Group Description	Use of pediatric size tubes for diagnostic blood collection.	Use of adult size tubes for diagnostic blood collection.
Period Title: Overall Study
STARTED	100	100
COMPLETED	100	100
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Pediatric Phlebotomy Tubes	Adult Phlebotomy Tubes	Total
Arm/Group Description	Use of pediatric size tubes for diagnostic blood collection.	Use of adult size tubes for diagnostic blood collection.	Total of all reporting groups
Overall Participants	100	100	200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55 (16.7)	57 (18.5)	56.2 (17.9)
Sex: Female, Male (Count of Participants)
Female	45 45%	51 51%	96 48%
Male	55 55%	49 49%	104 52%
Race/Ethnicity, Customized (Count of Participants)
Black	36 36%	46 46%	82 41%
White	38 38%	39 39%	77 38.5%
Other	26 26%	15 15%	41 20.5%
Region of Enrollment (Count of Participants)
United States	100 100%	100 100%	200 100%
Hemoglobin concentration at intensive care unit (ICU) admission (g/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [g/dL]	11.4 (2.4)	11.1 (2.3)	11.24 (2.35)
Time from ICU admission to randomization (hours) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [hours]	5.3	5.7	5.64
Estimated blood volume (liters) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [liters]	4.9	4.6	4.77
Number of participants with chronic hemodialysis (Count of Participants)
Count of Participants [Participants]	12 12%	12 12%	24 12%
Number of participants with chronic kidney disease but no dialysis (Count of Participants)
Count of Participants [Participants]	13 13%	11 11%	24 12%
Number of participants with active malignancy (Count of Participants)
Count of Participants [Participants]	5 5%	5 5%	10 5%
Number of participants with recent history of anemia (Count of Participants)
Count of Participants [Participants]	45 45%	47 47%	92 46%
Charlson comorbidity index (score on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [score on a scale]	3.0	4.0	3
ICU Admission Diagnosis (Count of Participants)
Infection	55 55%	46 46%	101 50.5%
Acute Cardiovascular Disorder	21 21%	24 24%	45 22.5%
Acute renal failure	40 40%	31 31%	71 35.5%
Metabolic disorder	32 32%	36 36%	68 34%
Non-infectious inflammatory disorder	19 19%	11 11%	30 15%
Other	22 22%	31 31%	53 26.5%
Number of participants who had invasive mechanical ventilation (Count of Participants)
Count of Participants [Participants]	50 50%	51 51%	101 50.5%
APACHE II score (score on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [score on a scale]	22.0	23.0	22

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pediatric Phlebotomy Tubes	Adult Phlebotomy Tubes
Arm/Group Description	Use of pediatric size tubes for diagnostic blood collection.	Use of adult size tubes for diagnostic blood collection.
Measure Participants	100	100
Count of Participants [Participants]	6 6%	11 11%

2. Secondary Outcome

Title	Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)
Description	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).
Time Frame	from time of randomization to completion of study (up to 30 days after ICU admission)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pediatric Phlebotomy Tubes	Adult Phlebotomy Tubes
Arm/Group Description	Use of pediatric size tubes for diagnostic blood collection.	Use of adult size tubes for diagnostic blood collection.
Measure Participants	100	100
Median (Inter-Quartile Range) [g/dL/day]	-0.21	-0.2

3. Secondary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pediatric Phlebotomy Tubes	Adult Phlebotomy Tubes
Arm/Group Description	Use of pediatric size tubes for diagnostic blood collection.	Use of adult size tubes for diagnostic blood collection.
Measure Participants	100	100
Count of Participants [Participants]	4 4%	9 9%

4. Secondary Outcome

Title	Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis
Description	An inadequate blood sample is defined as any blood sample that requires recollection.
Time Frame	completion of study (up to 30 days after ICU admission)

Outcome Measure Data

Analysis Population Description

This outcome data was not collected in the arm using adult phlebotomy tubes.

Arm/Group Title	Pediatric Phlebotomy Tubes	Adult Phlebotomy Tubes
Arm/Group Description	Use of pediatric size tubes for diagnostic blood collection.	Use of adult size tubes for diagnostic blood collection.
Measure Participants	100	0
Count of Participants [Participants]	7 7%

5. Secondary Outcome

Title	ICU Mortality
Time Frame	completion of study (up to 30 days after ICU admission)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pediatric Phlebotomy Tubes	Adult Phlebotomy Tubes
Arm/Group Description	Use of pediatric size tubes for diagnostic blood collection.	Use of adult size tubes for diagnostic blood collection.
Measure Participants	100	100
Count of Participants [Participants]	9 9%	10 10%

6. Secondary Outcome

Title	Total Phlebotomy Volume
Description	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.
Time Frame	completion of study (up to 30 days after ICU admission)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pediatric Phlebotomy Tubes	Adult Phlebotomy Tubes
Arm/Group Description	Use of pediatric size tubes for diagnostic blood collection.	Use of adult size tubes for diagnostic blood collection.
Measure Participants	100	100
Median (Inter-Quartile Range) [mL]	21	50

Adverse Events

Time Frame	time of randomization to completion of study (up to 30 days after ICU admission)
Adverse Event Reporting Description	Systematically assessed for RBC transfusion-related adverse events.
Arm/Group Title	Pediatric Phlebotomy Tubes		Adult Phlebotomy Tubes
Arm/Group Description	Use of pediatric size tubes for diagnostic blood collection.		Use of adult size tubes for diagnostic blood collection.
All Cause Mortality
	Pediatric Phlebotomy Tubes		Adult Phlebotomy Tubes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/100 (9%)		10/100 (10%)
Serious Adverse Events
	Pediatric Phlebotomy Tubes		Adult Phlebotomy Tubes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/100 (9%)		10/100 (10%)
General disorders
death	9/100 (9%)	9	10/100 (10%)	10
Other (Not Including Serious) Adverse Events
	Pediatric Phlebotomy Tubes		Adult Phlebotomy Tubes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/100 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.