Neonatal Platelet Transfusion Threshold Trial
Purpose
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).
Conditions
- Thrombocytopenia
- Neonatal
- Platelet Transfusion
- Infant, Newborn, Diseases
- Infant, Extremely Low Birth Weight
- Infant, Small for Gestational Age
- Thrombosis
Eligibility
- Eligible Ages
- Between 1 Hour and 48 Hours
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Gestational age of 23 0/7 to 26 6/7 weeks - Postnatal age of < 48 hours
Exclusion Criteria
- Comfort care or withdrawal of care planned - Neonatal alloimmune thrombocytopenia or suspected/confirmed congenital platelet or bleeding disorder - Receipt of platelet transfusion - No receipt of Vitamin K - Parents/guardian decline consent
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized trial with 1:1 allocation to parallel arms within strata of Study Center and gestational age (23-24 weeks and 25-26 weeks PMA). Multiples will be randomized independently. Approximately 30% of enrolled participants are expected to meet the platelet count threshold for randomization. The target sample size for randomization is 730, or 365 per arm.
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- There will be no blinding/masking of the treatment group allocation to providers or parents to ensure providers are aware of treatment allocation to guide platelet transfusions. This is necessary to ensure adherence to the treatment arms. However, a standard tool will be used to assess bleeding as described below and grading of the severity of bleeding will be performed centrally. In addition, radiologists interpreting cranial ultrasound findings will be blinded to treatment arm allocation.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Higher Platelet Transfusion Threshold |
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. |
|
|
Other Lower Platelet Transfusion Threshold |
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. |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35233
Waldemar A Carlo, MD
More Details
- Status
- Recruiting
- Sponsor
- NICHD Neonatal Research Network
Detailed Description
Thrombocytopenia, defined as a platelet count <150 x 10^9/L, is a common neonatal problem that affects 22% to 35% of infants admitted to the neonatal intensive care unit. Platelets are important for primary hemostasis to prevent blood extravasation after vascular injury. Based on the role of platelets in hemostasis, prophylactic platelet transfusions are routinely administered to preterm infants with thrombocytopenia to prevent bleeding. The incidence of thrombocytopenia and administration of platelet transfusion are both inversely related to the gestational age at birth. Currently, there is uncertainty regarding the optimal platelet transfusion threshold, particularly among the most immature infants in the first week of life, which represents the period of highest bleeding risk. The NeoPlaTT trial was designed to address this pressing uncertainty in the highest risk population (<27 weeks GA). It will test whether a threshold of 20x10^9/L could be safely used after the first week of life, when the risk of serious bleeding is significantly lower, and reduce the need for platelet transfusion altogether. The results of this study have a potential to change clinical practice and improve outcomes in this vulnerable population, while also decreasing costs and resource utilization. This is a randomized trial with 1:1 allocation to parallel arms. Infants, inborn or outborn, who are admitted to participating NICUs, and who meet the inclusion and exclusion criteria, will be invited to enroll into the trial for platelet count monitoring. Only consented and enrolled infants meeting the additional platelet count trigger of < 50 x 10^9/L (postnatal days 1-7) or <35 x 10^9/L (8 or more postnatal days) will be randomized. Postnatal day 1 starts at birth. Randomization will be allowed to occur up to 36 6/7 weeks' PMA; subjects will be monitored through 40 0/7 weeks PMA. Approximately 30% of consented and enrolled infants are expected to meet the platelet count threshold for randomization.