N/A
N=200
Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT03286465 ↗Enrolled (actual)
200
Serious AEs
9.5%
Results posted
Aug 2021
Primary outcome: Primary: Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order — 6; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pediatric phlebotomy tubes (Device); Adult phlebotomy tubes (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order |
6; 11 | — |
| SECONDARY Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU) |
-0.21; -0.2 | — |
| SECONDARY Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU |
4; 9 | — |
| SECONDARY Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis |
7 | — |
| SECONDARY ICU Mortality |
9; 10 | — |
| SECONDARY Total Phlebotomy Volume |
21; 50 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03286465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.