44
Participants
Start Date
March 31, 2016
Primary Completion Date
March 20, 2017
Study Completion Date
March 20, 2017
Liberal platelet transfusion
"Liberal platelet transfusion: In Intervention group the investigators will transfuse platelet concentrates to maintain a platelet count above 1,00,000 per microliter until one of the following endpoints is met, whichever is applicable:~1. PDA closes or~2. A maximum of 120 hours after the point of randomisation"
Restrictive platelet transfusion
"The investigators will transfuse platelets only if:~(i) Platelet count is \< 20,000 per microliter or (ii) Subject has a clinical bleed or (iii) Subject has platelet count \< 50000 per microliter and requires a major non-neurosurgical interventional procedure as per the current standard of care, or (iv) Subject has a platelet count \< 1, 00,000 per microliter and requires a neurosurgical procedure"
Paracetamol
"As all subjects recruited in the trial will have hemodynamically significant (hs) PDA, they will all be medically treated as per standard of care. Treatment regimens will be as follows, depending on the discretion of the treating physician:~Paracetamol:~Dosage-15 mg/kg/dose every 6 hourly x 12 doses Route - IV"
Ibuprofen
"As all subjects recruited in the trial will have hemodynamically significant (hs) PDA, they will all be medically treated as per standard of care. Treatment regimens will be as follows, depending on the discretion of the treating physician:~Ibuprofen:~Dosage-10 mg/kg stat followed by 5 mg/kg/dose x 2 doses at 24 hours intervals Route- oral"
Post Graduate Institute of Medical Education and Research, Chandigarh
Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER