Platelet Transfusion Thresholds for Low Platelet Count in Premature Infants

(NeoPlaTT Trial)

Recruiting at 19 trial locations

Overseen By Ravi M Patel, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: NICHD Neonatal Research Network

Disqualifiers: Comfort care, Thrombocytopenia, No Vitamin K, others

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

Compensation: Varies

Number of Visits: Unknown

2433 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a lower threshold for platelet transfusions in extremely premature infants can improve survival without severe bleeding. Platelets aid in blood clotting, and the study compares two platelet transfusion levels: a higher threshold and a lower threshold. Infants born very early, between 23 and 26 weeks of pregnancy, who are less than 48 hours old, may be eligible to participate. The goal is to identify which transfusion level benefits these infants most while minimizing the risk of major bleeding. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance care for extremely premature infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using a higher threshold for platelet transfusions in preterm infants might not be the safest choice. Studies found that infants with a higher threshold, such as 50, experienced more deaths or major bleeding compared to those with a lower threshold of 25. One study revealed that 27.5% of infants in the high-threshold group received at least one transfusion, while only 16.1% did in the low-threshold group.

With a lower platelet transfusion threshold, fewer infants required transfusions. For instance, only 53% of infants in the low-threshold group received transfusions, compared to 90% in the high-threshold group. This suggests that a lower threshold might be safer, as it results in fewer transfusions and possibly fewer complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different platelet transfusion thresholds for premature infants with low platelet counts, which could lead to better outcomes. Unlike the standard approach that typically involves a uniform transfusion threshold, this trial tests both higher and lower thresholds tailored to different stages of an infant’s early life. By fine-tuning the threshold levels, the trial may reveal insights into optimizing transfusion needs, potentially reducing unnecessary interventions and associated risks. This could pave the way for more personalized care in managing low platelet counts in these vulnerable infants.

What evidence suggests that this trial's treatments could be effective for low platelet count in premature infants?

Research has shown that preterm babies often receive platelet transfusions at higher levels to prevent bleeding, as more platelets are believed to lower bleeding risk. However, new evidence suggests that transfusions at a lower level might be more beneficial. In this trial, participants will be randomized into two groups: one receiving transfusions at a higher threshold and another at a lower threshold. Specifically, one study found that babies who received transfusions at lower levels had a lower risk of death or severe bleeding. In that study, only 53% of babies in the low-level group needed transfusions, compared to 90% in the high-level group. This suggests that a lower level might be just as effective, or even better, at preventing problems. ^{6 7 8 9 10}

Who Is on the Research Team?

Ravi Patel, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for extremely preterm infants born between 23 and nearly 27 weeks of gestation. It's designed to help those with low platelet counts, which can lead to bleeding and other complications.

Inclusion Criteria

Gestational age of 23 0/7 to 26 6/7 weeks

I am a newborn less than 48 hours old.

Exclusion Criteria

Parents/guardian decline consent

I have not taken Vitamin K.

I am receiving comfort care or planning to withdraw care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Randomization and Monitoring

Infants are randomized to either a higher or lower platelet transfusion threshold and monitored for platelet counts

Up to 36 6/7 weeks postmenstrual age

Continuous monitoring in NICU

Follow-up

Participants are monitored for survival without major or severe bleeding and other outcomes

Up to 40 0/7 weeks postmenstrual age

What Are the Treatments Tested in This Trial?

Interventions

• Higher Platelet Transfusion Threshold
• Lower Platelet Transfusion Threshold

Trial Overview The NeoPlaTT trial compares two strategies for platelet transfusions in these infants: one uses a higher threshold before transfusion, while the other uses a lower threshold. The goal is to see which approach is better for survival without major bleeding by about 40 weeks after their due date.

How Is the Trial Designed?

Group I: Lower Platelet Transfusion Threshold Experimental Treatment 1 Intervention

Infants randomized to this arm will be monitored for a platelet transfusion threshold of 25 x 10\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 20 x 10\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.

Group II: Higher Platelet Transfusion Threshold Active Control 1 Intervention

Infants randomized to this arm will be monitored for a platelet transfusion threshold of 50 x 10\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 35 x 10\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.

Who Is Running the Clinical Trial?

NICHD Neonatal Research Network

Lead Sponsor

Trials

62

Recruited

209,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. thelancet.com thelancet.com/journals/lanepe/article/PIIS2666-7762(24)00253-9/fulltext

Platelet transfusion in neonatal intensive care units of 22 ... We found that 8.3% of very preterm infants received at least one platelet transfusion during the first 28 days after birth. The primary ...

2. ahajournals.org ahajournals.org/doi/10.1161/ATVBAHA.123.319252

Platelet Transfusions in Neonates: Beyond Hemostasis Preterm neonates have historically been transfused at higher platelet counts than older children and adults, based on the assumption that increasing the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11362868/

Judicious Transfusion of Platelets Among Neonates It was usual clinical practice that neonates should be transfused with higher platelet counts than older children or adults to reduce their risk of bleeding.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820028

Clinical Practice Guideline for Red Blood Cell Transfusion ... In 2020, the 2 largest randomized clinical trials (RCTs) comparing high vs low thresholds for RBC transfusion in very preterm neonates were ...

5. nature.com nature.com/articles/s41372-021-01033-6

Implementation of a neonatal platelet transfusion guideline ... Thrombocytopenia, defined as a platelet count <150 × 109/L, affects 18–35% of all patients admitted to the Neonatal Intensive Care Unit (NICU).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10447411/

Two-year outcomes following a randomised platelet ... A higher platelet transfusion threshold was associated with significantly increased mortality or major bleeding compared to a lower one.

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa1807320

Randomized Trial of Platelet-Transfusion Thresholds in ... A randomized trial comparing prophylactic platelet-transfusion thresholds in neonates showed no benefit of maintaining a “normal” platelet count.

8. nature.com nature.com/articles/s41372-025-02444-5

Using a lower platelet transfusion threshold At two year follow-up, the odds of death or neurodevelopmental impairment were increased in the high threshold group (OR 1.54, 95% CI 1.09–2.07) ...

9. web.musc.edu web.musc.edu/-/sm/medicine/education/cme/current/handouts/2024-neonatal-conference/less-is-more-transusion-thresholds-in-preterm-infants-ashley-osborne.pdf

Less is More: Transfusion Thresholds in Preterm Infants Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants. ... Two-year outcomes following a randomised platelet transfusion trial in preterm infants.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11413073/

Lowering platelet-count threshold for transfusion in preterm ... In the high-threshold group, 99/360 (27.5%) received at least one platelet transfusion as compared with 56/347 (16.1%) in the low-threshold ...