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

Trial Summary

What is the purpose of this trial?

The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without major or severe bleeding up to 40 0/7 weeks' postmenstrual age (PMA).

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment for platelet transfusion thresholds in premature infants?

Research shows that using a lower platelet transfusion threshold of 25 x 10^9/L in premature infants can reduce the risk of major bleeding and death compared to a higher threshold of 50 x 10^9/L. This approach has been associated with a 7% reduction in absolute risk of these adverse outcomes. ^{1 2 3 4 5}

Is platelet transfusion safe for premature infants with low platelet counts?

Recent studies suggest that using a lower threshold for platelet transfusions in premature infants may be safer, as higher thresholds have been linked to increased risks of death and bleeding. However, there is still a need for more research to fully understand the safety and best practices for platelet transfusions in these infants. ^{1 6 7 8 9}

How does the treatment of different platelet transfusion thresholds for low platelet count in premature infants differ from other treatments?

This treatment is unique because it explores different thresholds for platelet transfusions in premature infants, specifically comparing higher and lower platelet count thresholds. Recent studies suggest that a lower threshold (25 x 10^9/L) may be safer and more effective, as higher thresholds could increase the risk of harm, including death and bleeding, due to potential disruptions in the infant's delicate blood balance. ^{1 3 6 9 10}

Research Team

Ravi Patel, MD

Principal Investigator

Emory University

Eligibility Criteria

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

I have not taken Vitamin K.

I am receiving comfort care or planning to withdraw care.

I have a history of bleeding or platelet disorders since birth.

Timeline

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

Treatment Details

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.

Participant Groups

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 up to 7 days of life, and then for a platelet transfusion threshold of 20 x 10\^9/L at 7 or more 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 up to 7 days of life, and then for a platelet transfusion threshold of 35 x 10\^9/L at 7 or more 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+

References

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

Benefits of lower neonatal platelet transfusion thresholds. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Platelet transfusion for neonates with thrombocytopaenia: protocol for a systematic review. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Platelet transfusion thresholds in premature neonates (PlaNeT-2 trial). [2019]

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

Platelets in the neonatal period: developmental differences in platelet production, function, and hemostasis and the potential impact of therapies. [2016]

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

Preterm neonates benefit from low prophylactic platelet transfusion threshold despite varying risk of bleeding or death. [2021]

6. Ireland pubmed.ncbi.nlm.nih.gov

Platelet transfusion thresholds in neonatal medicine. [2020]

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

Prophylactic platelet transfusion in children with thrombocytopenic disorders: a retrospective review. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Platelet transfusion in the management of severe thrombocytopenia in neonatal intensive care unit patients. [2019]

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

Thrombocytopenia, bleeding, and use of platelet transfusions in sick neonates. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Are thrombocytopenia and platelet transfusions associated with major bleeding in preterm neonates? A systematic review. [2020]