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

Anemia Clinical Trial

Official title:

Pilot, Randomized Trial of the Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03286465
• Other study ID #: HSC-MS-17-0280
• Status: Completed
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: August 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Critical Illness

Intervention

Device:
• Pediatric phlebotomy tubes
Use of pediatric size tubes for diagnostic blood collection.
• Adult phlebotomy tubes
Use of adult size tubes for diagnostic blood collection.

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	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		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.	completion of study (up to 30 days after ICU admission)
Secondary	ICU Mortality		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.	completion of study (up to 30 days after ICU admission)