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

NCT03022253 | Completed Phase 3

• 1 other identifier: INT/IEC/2016/1090
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Patent ductus arteriosus (PDA) is a common problem in preterm babies. Recently there have been various studies for and against an association between thrombocytopenia and PDA. A meta-analysis published in 2015 showed a marginally significant positive association between PDA and thrombocytopenia but these were all observational studies and there are no randomized controlled trials (RCT) on it. The investigators decided to conduct an RCT to determine whether liberal platelet transfusion criteria achieve earlier PDA closure rates than standard restrictive platelet transfusion criteria among thrombocytopenic preterm neonates (\<35 weeks' gestation) with hemodynamically significant PDA presenting within the first 14 days of life. The investigators primary objective is to determine whether liberal platelet transfusion criteria achieve earlier PDA closure rates within 120 hours compared to standard restrictive platelet transfusion criteria among thrombocytopenic preterm neonates (\<35 weeks' gestation) with hemodynamically significant PDA presenting within the first 14 days of life. The investigators will stratify the study population based on platelet count, i.e \< 50000 and 50000-100000 per microlitre, and will randomly allocate participants to control and intervention group. Babies in the intervention group will receive platelet transfusion to maintain the platelet count above 100,000 per microlitre. Babies in control group will receive platelets only when clinically indicated and as per current standard indications. The investigators will perform an echocardiogram at baseline to document a hemodynamically significant PDA (hsPDA) and then serially to look for the closure of PDA. Medical management of PDA will be as per unit policy. The investigators will follow the baby till PDA closes or 120 hours post randomization.

Conditions

Patent Ductus Arteriosus

Keywords

PDA; Platelets

Outcome Measures

Primary Outcomes (1)

• Time to closure of PDA post randomization

  Time point at which closure (Absence of flow in PDA on colour doppler) is documented first time will be considered as time to closure of PDA

  within 120 hours post randomisation

Secondary Outcomes (10)

• Proportion of participants in whom PDA is open

  at 120 hours after randomization

• Proportion of participants in whom PDA is echocardiographically hemodynamically significant

  at 120 hours after randomization

• Cumulative volume of platelet concentrate received

  within 120 hours after randomization

• Number of participants with Clinical bleed of any kind ( defined below)

  within 120 hours after randomization

• New onset IVH of any grade

  within 120 hours after randomization

Study Arms (2)

Liberal Platelet transfusion group

EXPERIMENTAL

Platelet transfusion to maintain a platelet count above 1,00,000 per microliter until one of the endpoints is met. 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 Paracetamol: Dosage-15 mg/kg/dose every 6 hourly x 12 doses Route - IV

Biological: Liberal platelet transfusion; Drug: Paracetamol; Drug: Ibuprofen

Restrictive platelet transfusion group

ACTIVE COMPARATOR

Platelet transfusion for standard criteria. 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 Paracetamol: Dosage-15 mg/kg/dose every 6 hourly x 12 doses Route - IV

Biological: Restrictive platelet transfusion; Drug: Paracetamol; Drug: Ibuprofen

Interventions

Liberal platelet transfusion BIOLOGICAL

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

Liberal Platelet transfusion group

Restrictive platelet transfusion BIOLOGICAL

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

Restrictive platelet transfusion group

Paracetamol DRUG

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

Also known as: Crocin

Liberal Platelet transfusion group; Restrictive platelet transfusion group

Ibuprofen DRUG

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

Also known as: Brufen

Liberal Platelet transfusion group; Restrictive platelet transfusion group

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age up to 34 6/7 weeks
• PDA detected for the first time at less than 14 days of postnatal age
• Clinically and/or echocardiographically hemodynamically significant PDA Note: ELBW neonates will be screened in first 48 hours as per unit policy; the rest will undergo echocardiography only when there are clinical signs of PDA.

You may not qualify if:

• Echocardiographically proven structural congenital heart disease.
• Major life-threatening malformation
• Received platelet concentrate between the last available platelet count and the point of randomisation

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

Related Publications (59)

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• Kumar J, Dutta S, Sundaram V, Saini SS, Sharma RR, Varma N. Platelet Transfusion for PDA Closure in Preterm Infants: A Randomized Controlled Trial. Pediatrics. 2019 May;143(5):e20182565. doi: 10.1542/peds.2018-2565. Epub 2019 Apr 2.

  PMID: 30940676 DERIVED

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Acetaminophen; crocin; Ibuprofen

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Sourabh Dutta, MD

  Post Graduate Institute of Medical Education and Research; Chandigarh, India

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 25, 2016
• First Posted: January 16, 2017
• Study Start: March 1, 2016
• Primary Completion: March 20, 2017
• Study Completion: March 20, 2017
• Last Updated: April 6, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)