Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell … (NCT03286465) | Clinical Trial Compass
CompletedNot Applicable
Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions
United States200 participantsStarted 2017-11-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order
Timeframe: from time of admission to intensive care unit (ICU) to 30 days after admission to ICU
Trial details
NCT IDNCT03286465
SponsorThe University of Texas Health Science Center, Houston