NCT03286465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 7, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

August 30, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

September 14, 2017

Results QC Date

September 22, 2019

Last Update Submit

August 3, 2021

Conditions

Anemia

Keywords

blood transfusion

Outcome Measures

Primary Outcomes (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 Outcomes (5)

  • 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)

  • 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)

  • Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis

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

  • ICU Mortality

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

  • Total Phlebotomy Volume

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

Study Arms (2)

Pediatric phlebotomy tubes

EXPERIMENTAL

Use of pediatric size tubes for diagnostic blood collection.

Device: Pediatric phlebotomy tubes

Adult phlebotomy tubes

ACTIVE COMPARATOR

Use of adult size tubes for diagnostic blood collection.

Device: Adult phlebotomy tubes

Interventions

Pediatric phlebotomy tubesDEVICE

Use of pediatric size tubes for diagnostic blood collection.

Pediatric phlebotomy tubes
Adult phlebotomy tubesDEVICE

Use of adult size tubes for diagnostic blood collection.

Adult phlebotomy tubes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New admission to the medical or transplant ICU at Memorial Hermann Hospital in Houston
  • Randomization is expected within 12 hour of admission to the ICU

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Barreda Garcia J, Xian JZ, Pedroza C, Salahuddin M, Mak G, Keene A, Cherian SV, Young AY, Vijhani P, Doshi PB. Pediatric size phlebotomy tubes and transfusions in adult critically ill patients: a pilot randomized controlled trial. Pilot Feasibility Stud. 2020 Aug 8;6:112. doi: 10.1186/s40814-020-00657-3. eCollection 2020.

    PMID: 32782818DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Javier Barreda Garcia, MD
Organization
The University of Texas Health Science Center at Houston
Javier.BarredaGarcia@uth.tmc.edu
713-500-6838

Study Officials

  • Javier Barreda Garcia, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 18, 2017

Study Start

November 7, 2017

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

August 30, 2021

Results First Posted

August 30, 2021

Record last verified: 2021-08

Locations

US(1)