bleeding Hemorrhage
Conditions
Interventions
Randomization between a thrombocyte transfusion threshold of 50x10^9/L and a
thrombocyte transfusion threshold of 25x10^9/L.
Sponsors
National Health Services Blood and Transplant (NHSBT), UK
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained 2. Admission to a participating NICU (includes postnatal transfer) 3.
Exclusion criteria
Exclusion criteria: 1. Major/life-threatening congenital malformations (e.g. chromosomal anomalies, Fanconi*s anaemia, Thrombocytopenia Absent Radius syndrome (TAR)); 2. The occurrence of a major/ severe bleed within the previous 72 hours. However, the neonate may be eligible for randomisation later, once 72 hours has elapsed, provided there are no further major bleeds and the baby meets all the inclusion criteria; 3. All foetal intracranial haemorrhages excluding subependymal haemorrhage from any antenatal ultrasound scan; 4. Known immune thrombocytopenia or family history of alloimmune thrombocytopenia or maternal antiplatelet antibodies or maternal idiopathic thrombocytopenic purpura; 5. Neonates judged by the attending neonatologist to be unlikely to survive more than a few hours at the time of proposed randomisation; 6. Neonates who were not given parenteral Vitamin K after birth.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who either die or experience a major bleed up to and including study day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of patients surviving to go home following a major bleed • Proportion of patients surviving to go home without having had a major bleed • Proportion of patients who have died up to study day 28 • Proportion of patients who sustain a major bleed up to study day 28 • The rate and time from randomization of minor, moderate and major bleeding derived from the bleeding assessment tool up to study day 14, and for major bleeds up to study day 28. • Number of platelet units transfused up to study day 28 • Time to discharge home • Neuro-developmental outcome as assessed by the Bayley III scale of infant development or a Dutch self-completion questionnaire (PARCA-R: Parent Report of Children*s Abilities for very Premature Infants) and a supplementary questionnaire designed specifically for MATISSE. This assessment will take place at 2 year corrected postnatal age. • Platelet transfusion-related adverse events up to discharge | — |
Countries
Netherlands
Outcome results
None listed