Platelet Transfusion for Treatment of Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates

PHASE3CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

March 20, 2017

Study Completion Date

March 20, 2017

Conditions
Patent Ductus Arteriosus
Interventions
BIOLOGICAL

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"

BIOLOGICAL

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"

DRUG

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"

DRUG

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"

Trial Locations (1)

160012

Post Graduate Institute of Medical Education and Research, Chandigarh

All Listed Sponsors
lead

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

NCT03022253 - Platelet Transfusion for Treatment of Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates | Biotech Hunter | Biotech Hunter