NCT03286465

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

Completed NA Results posted Last updated 30 August 2021

What this trial tests

NA trial testing Pediatric phlebotomy tubes in Anemia in 200 participants. Completed in 30 September 2018.

Timeline

7 November 2017

Primary endpoint
30 September 2018

30 September 2018

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	200
Start date	7 November 2017
Primary completion	30 September 2018
Estimated completion	30 September 2018
Sites	1 location across United States

Drugs / interventions tested

• Pediatric phlebotomy tubes
• Adult phlebotomy tubes

Conditions studied

• Anemia — all drugs for Anemia →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

18 and older, any sex, with Anemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order Primary · from time of admission to intensive care unit (ICU) to 30 days after admission to ICU

Group	Value	95% CI
Pediatric Phlebotomy Tubes	6
Adult Phlebotomy Tubes	11

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

Group	Value	95% CI
Pediatric Phlebotomy Tubes	-0.21	-0.48 – 0.021
Adult Phlebotomy Tubes	-0.2	-0.54 – 0.038

Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU Secondary · completion of study (up to 30 days after ICU admission)

Group	Value	95% CI
Pediatric Phlebotomy Tubes	4
Adult Phlebotomy Tubes	9

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

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

Group	Value	95% CI
Pediatric Phlebotomy Tubes	7

ICU Mortality Secondary · completion of study (up to 30 days after ICU admission)

Group	Value	95% CI
Pediatric Phlebotomy Tubes	9
Adult Phlebotomy Tubes	10

Total Phlebotomy Volume Secondary · 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.

Group	Value	95% CI
Pediatric Phlebotomy Tubes	21	7 – 38
Adult Phlebotomy Tubes	50	27 – 100

Adverse events — posted to ClinicalTrials.gov

Time frame: time of randomization to completion of study (up to 30 days after ICU admission). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pediatric Phlebotomy Tubes

Serious: 9/100 (9%)

Deaths: 9/100

Adult Phlebotomy Tubes

Serious: 10/100 (10%)

Deaths: 10/100

Serious adverse events (1 terms)

Reaction	System	Pediatric Phlebotomy Tubes	Adult Phlebotomy Tubes
death	General disorders	—	—

Most-reported serious reactions: death.

Data from ClinicalTrials.gov NCT03286465 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pediatric size phlebotomy tubes and transfusions in adult critically ill patients: a pilot randomized controlled trial.
   Barreda Garcia J, Xian JZ, Pedroza C, Salahuddin M, et al · · 2020 · cited 10× · PMID 32782818 · DOI 10.1186/s40814-020-00657-3