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

Not Applicable

Completed

• Conditions: Anemia
• Interventions: Device: Adult phlebotomy tubes; Device: Pediatric phlebotomy tubes

• Registration Number: NCT03286465
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-14
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-18
• Study Start: 2017-11-07
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Results First Submitted: 2019-09-22
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-03
• Last Update Submitted: 2021-08-03
• Results First Posted: 2021-08-30
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adult phlebotomy tubes	Adult phlebotomy tubes	Use of adult size tubes for diagnostic blood collection.
Pediatric phlebotomy tubes	Pediatric phlebotomy tubes	Use of pediatric size tubes for diagnostic blood collection.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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).
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.
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)
ICU Mortality	completion of study (up to 30 days after ICU admission)

Trial Locations

Locations (1)

Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States