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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-07

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pediatric phlebotomy tubes

Use of pediatric size tubes for diagnostic blood collection.

Group Type EXPERIMENTAL

Pediatric phlebotomy tubes

Intervention Type DEVICE

Use of pediatric size tubes for diagnostic blood collection.

Adult phlebotomy tubes

Use of adult size tubes for diagnostic blood collection.

Group Type ACTIVE_COMPARATOR

Adult phlebotomy tubes

Intervention Type DEVICE

Use of adult size tubes for diagnostic blood collection.

Interventions

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Pediatric phlebotomy tubes

Use of pediatric size tubes for diagnostic blood collection.

Intervention Type DEVICE

Adult phlebotomy tubes

Use of adult size tubes for diagnostic blood collection.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No