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

Trial Summary

What is the purpose of this trial?

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 Intermediate care unit (IMU) patients with low hemoglobin compared with standard size tubes, to compare the intervention and the control groups in regards to: ICU length of stay (LOS), ICU mortality, hospital LOS, and hospital mortality and to assess the acceptability of small phlebotomy tubes in adult ICU and IMU patients.

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 data supports the effectiveness of using small phlebotomy tubes as a treatment for anemia in ICU patients?

Research shows that using small-volume phlebotomy tubes can reduce blood loss during tests, which may help decrease anemia and the need for blood transfusions in ICU patients. ^{1 2 3 4 5}

Is the use of small phlebotomy tubes safe for humans?

Research indicates that using small phlebotomy tubes in intensive care units can reduce blood loss and the need for blood transfusions, which are generally safe practices for managing anemia in critically ill patients. ^{1 2 4 5 6}

How is the Small Phlebotomy Tube treatment different from other treatments for anemia in ICU patients?

The Small Phlebotomy Tube treatment is unique because it uses smaller tubes to collect blood, which reduces the total amount of blood taken from patients. This can help decrease the risk of anemia and the need for blood transfusions in ICU patients, unlike standard larger-volume blood collection methods. ^{1 2 3 4 7}

Research Team

Javier Barreda Garcia, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

I do not have a bone marrow disorder or recent chemotherapy.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Netherlands 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of minimizing diagnostic blood loss in the critically ill. [2019]

3. Lebanon pubmed.ncbi.nlm.nih.gov

Evaluation of a blood conservation strategy in the intensive care unit: a prospective, randomised study. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Safe Reduction of Blood Volume in the Blood Gas Laboratory. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Validation of a New Small-Volume Sodium Citrate Collection Tube for Coagulation Testing in Critically Ill Patients with Coagulopathy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Highly conservative phlebotomy in adult intensive care--a prospective randomized controlled trial. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Interventions to prevent iatrogenic anemia: a Laboratory Medicine Best Practices systematic review. [2020]