Small Phlebotomy Tubes for Anemia in ICU Patients

Overseen By Ibilola A Sanusi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Clinical bleeding, Hemolytic disorder, Bone marrow disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

688 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether smaller blood collection tubes (Small Phlebotomy Tubes) can reduce the need for blood transfusions in ICU patients with anemia (low red blood cell count). Researchers aim to determine if these smaller tubes can lead to shorter hospital stays and lower death rates compared to standard-sized tubes. The trial will also assess patient acceptance of these smaller tubes. It seeks ICU patients with hemoglobin levels below 10 g/dL, excluding those who are actively bleeding or have certain blood disorders. As an unphased trial, this study provides patients the chance to contribute to innovative research that could enhance ICU care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that small phlebotomy tubes are safe for ICU patients?

Research shows that small blood collection tubes are generally well-tolerated by ICU patients. Studies have found that these smaller tubes can significantly reduce blood loss. For example, one study reported a reduction of about 82.8 mL of blood loss for patients with a short ICU stay. Another study found that small tubes can lead to fewer blood transfusions, indicating improved safety.

Overall, existing research does not report any major negative effects specifically linked to small blood collection tubes. These tubes are part of a broader effort to manage anemia (a low red blood cell count) and have proven practical and well-tolerated in similar situations. This suggests they are a safe option for ICU patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of small phlebotomy tubes for anemia in ICU patients because they could significantly reduce the volume of blood taken for testing. Unlike standard phlebotomy tubes, which often contribute to blood loss and exacerbate anemia in critically ill patients, small tubes limit blood draw to the bare minimum needed for accurate testing. This approach may reduce the need for blood transfusions, which are the current standard treatment for anemia but come with risks like infections and immune reactions. By minimizing blood loss, these small tubes could improve patient outcomes and reduce hospital stays.

What evidence suggests that small phlebotomy tubes are effective for reducing RBC transfusions in ICU patients with anemia?

This trial will compare small phlebotomy tubes with standard ones in ICU patients. Research has shown that smaller blood collection tubes can reduce the need for blood transfusions in these patients. Studies have found that only about 10% of the blood drawn is used for tests. Thus, smaller samples might decrease anemia (a condition with insufficient healthy red blood cells) and reduce transfusion needs. Evidence also suggests that smaller tubes can reduce blood drawn by up to 50% for some tests. Despite some uncertainties in the data, these findings indicate potential benefits in reducing blood loss and improving ICU patient care. ^{1 2 3 4 6}

Who Is on the Research Team?

Javier Barreda Garcia, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults in the ICU or IMU with anemia, specifically those with hemoglobin levels below 9 g/dL. It's not suitable for patients with active bleeding, blood or bone marrow disorders, Jehovah's Witnesses, those on comfort care only, refractory shock patients, severe acidosis cases without diabetic ketoacidosis, surgical admission diagnoses, pregnant women or prisoners.

Inclusion Criteria

Hemoglobin less than 10 g/dL

I am admitted to the medical ICU or IMU.

Exclusion Criteria

My blood pressure remains low despite high doses of 3 different blood pressure medications.

Jehovah's Witnesses

Severe acidosis: pH below 7 in more than one arterial blood gas in the past 24 hours, in the absence of diabetic ketoacidosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are assigned to either the small phlebotomy tube group or the standard tube group to evaluate the effectiveness in reducing RBC transfusions

4-6 weeks

Follow-up

Participants are monitored for ICU length of stay, ICU mortality, hospital length of stay, and hospital mortality

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Small Phlebotomy Tube Group
• Standard Phlebotomy Tube Group

Trial Overview The study compares small phlebotomy tubes against standard ones to see if they reduce the need for red blood cell transfusions in anemic ICU/IMU patients. It also looks at how these groups differ in terms of ICU/hospital stay length and mortality rates while assessing the acceptability of using small tubes.

How Is the Trial Designed?

Group I: Small Tube Group Experimental Treatment 1 Intervention

Group II: Standard Tube Group Active Control 1 Intervention

Small Phlebotomy Tube Group is already approved in Canada for the following indications:

Approved in Canada as Small Phlebotomy Tubes for:

• Reducing blood transfusions in adult medical intensive care unit and intermediate care unit patients with anemia

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

The use of small-volume phlebotomy tubes (SVPT) significantly reduced the total blood volume drawn from critically ill patients compared to conventional-volume tubes (CVPT), with an average reduction from 299 mL to 174 mL.

Daily blood draws were also lower with SVPT, averaging 22.5 mL compared to 31.7 mL with CVPT, suggesting that SVPT may help decrease the risk of anemia and the need for blood transfusions in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of minimizing diagnostic blood loss in the critically ill. Dolman, HS., Evans, K., Zimmerman, LH., et al.[2019]

A combination strategy using closed arterial blood gas sampling and pediatric vials significantly reduced blood loss from phlebotomy in ICU patients, with a mean loss of 15.16 ml compared to 45.11 ml in the standard method (p<0.001).

While the decline in hemoglobin levels was smaller in the combination group (0.79 g/dL) compared to the standard group (1.30 g/dL), this difference was not statistically significant, suggesting potential benefits for hemoglobin preservation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a blood conservation strategy in the intensive care unit: a prospective, randomised study. Mahdy, S., Khan, EI., Attia, M., et al.[2015]

Switching to a 1 mL blood gas syringe in the ICU significantly reduced the volume of blood drawn by 60%, which can help minimize iatrogenic anemia in patients.

The use of the 1 mL syringe did not compromise the integrity of laboratory specimens, ensuring that testing accuracy and reporting remained unaffected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe Reduction of Blood Volume in the Blood Gas Laboratory. Jensen, PR., Markewitz, BA.[2018]

A study involving 46 critically ill patients showed that small-volume (1.8 mL) sodium citrate tubes for coagulation testing produced results that are interchangeable with conventional (3 mL) tubes, indicating their reliability for accurate testing.

Using small-volume tubes reduced blood loss by about 40%, suggesting they should be adopted as the new standard of care to minimize unnecessary blood loss in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a New Small-Volume Sodium Citrate Collection Tube for Coagulation Testing in Critically Ill Patients with Coagulopathy. Adam, EH., Zacharowski, K., Hintereder, G., et al.[2019]

Using small volume vacuum phlebotomy tubes (SVTs) in ICU patients significantly reduced the drop in hemoglobin levels and the incidence of severe anemia during short admissions (2-7 days), based on an analysis of 318 patients.

The switch to SVTs did not affect the need for blood transfusions and successfully halved the daily blood sampling volume without increasing laboratory errors, indicating a safer and more efficient blood conservation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Small volume vacuum phlebotomy tubes: a controlled before-and-after study of a patient blood management initiative in an Australian adult intensive care unit. Briggs, EN., Hawkins, DJ., Hodges, AM., et al.[2020]

Devices that return blood from venous or arterial lines to patients can reduce blood loss by about 25% in both neonatal and adult ICU patients, based on a systematic review of 21 studies.

While the evidence suggests that using small volume tubes may lower the risk of anemia, it was not sufficient to determine their impact on overall blood loss or hemoglobin levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to prevent iatrogenic anemia: a Laboratory Medicine Best Practices systematic review. Whitehead, NS., Williams, LO., Meleth, S., et al.[2020]

A survey of Australian intensive care units revealed that only 16% return deadspace volumes from in-line arterial sets, and no units used pediatric-sized blood collection tubes, highlighting variability in phlebotomy practices.

Implementing a highly conservative phlebotomy protocol significantly reduced blood loss by over 80% (from 40 ml to 8 ml), suggesting that this approach is feasible and can help mitigate anemia in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Highly conservative phlebotomy in adult intensive care--a prospective randomized controlled trial. Harber, CR., Sosnowski, KJ., Hegde, RM.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10570918/

Small-Volume Blood Collection Tubes to Reduce ... Use of small-volume blood collection tubes in the ICU may decrease RBC transfusions without affecting laboratory analysis. Trial Registration.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05750654

Effectiveness of Small Phlebotomy Tubes in Reducing ... The purpose of this study is to evaluate the effectiveness of small phlebotomy tubes to reduce RBC transfusions in medical intensive care unit (ICU) and ...

3. ashpublications.org ashpublications.org/blood/article/134/Supplement_1/3685/428335/Small-Volume-Tubes-to-Reduce-Anemia-and

Small-Volume Tubes to Reduce Anemia and Transfusion ... Only 10% of the blood collected is used for testing suggesting that lower sample volumes may reduce the incidence/severity of anemia and use of ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/aas.14497

Small‐volume blood sample collection tubes in adult ... While the evidence is limited by uncertainty, the use of small-volume tubes appears to result in small reductions in the proportion of patients ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10884058/

Effect of using smaller blood volume tubes and closed blood ... Our results indicate that using small-volume tubes could reduce the amount of blood drawn by 50% for ABG, by 45% for serum, by 33.4% for EDTA, ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832015

Practical Anemia Bundle and Hemoglobin Recovery in ... This randomized clinical trial found that a multifaceted anemia prevention and treatment bundle was feasible, was well tolerated, and improved ...