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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03022253
Recruitment Status : Completed
First Posted : January 16, 2017
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Sourabh Dutta, Postgraduate Institute of Medical Education and Research

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.


Condition or disease Intervention/treatment Phase
Patent Ductus Arteriosus Biological: Liberal platelet transfusion Biological: Restrictive platelet transfusion Drug: Paracetamol Drug: Ibuprofen Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Liberal Versus Restrictive Platelet Transfusion for Treatment of Hemodynamically Significant Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates- A Randomized Open Label, Controlled Trial
Study Start Date : March 2016
Actual Primary Completion Date : March 20, 2017
Actual Study Completion Date : March 20, 2017


Arm Intervention/treatment
Experimental: Liberal Platelet transfusion group

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

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

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

Other Name: Crocin

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

Other Name: Brufen

Active Comparator: Restrictive platelet transfusion group

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

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

Other Name: Crocin

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

Other Name: Brufen




Primary Outcome Measures :
  1. Time to closure of PDA post randomization [ Time Frame: within 120 hours post randomisation ]
    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


Secondary Outcome Measures :
  1. Proportion of participants in whom PDA is open [ Time Frame: at 120 hours after randomization ]
    PDA will be considered open if there is presence of flow on colour doppler

  2. Proportion of participants in whom PDA is echocardiographically hemodynamically significant [ Time Frame: at 120 hours after randomization ]
    hemodynamic significance is defined somewhere else in text

  3. Cumulative volume of platelet concentrate received [ Time Frame: within 120 hours after randomization ]
    Total volume in ml/kg will be recorded

  4. Number of participants with Clinical bleed of any kind ( defined below) [ Time Frame: within 120 hours after randomization ]
    Any visible fresh oral, nasal, endotracheal, gastrointestinal or skin bleed will be considered as clinical bleed.

  5. New onset IVH of any grade [ Time Frame: within 120 hours after randomization ]
    Cranial ultrasound will be done as per protocol to look for IVH

  6. New onset IVH of grade 3or 4 [ Time Frame: within 120 hours after randomization ]
    Cranial ultrasound will be done as per protocol to look for IVH

  7. Mortality [ Time Frame: within 120 hours after randomization ]
    It stands for all cause mortality

  8. Mortality [ Time Frame: All subjects will be part of the study until death or discharge from the hospital. Timeframe for measuring mortality as an outcome is from the point of randomisation through the study period which will be approximately upto 30 days post randomisation ]
    It stands for all cause mortality

  9. Duration of hospital stay [ Time Frame: All subjects will be part of the study until death or discharge from the hospital.Timeframe for measuring duration of hospital stay is from the point of randomisation through the study period which will be approximately upto 30 days post randomisation ]
    Duration of stay will be from date of birth to date of discharge/referral or death

  10. Reopening rate of PDA that had initially closed [ Time Frame: within 120 hours of randomization ]
    It will include situation where PDA closure was documented on two consecutive occasions 24 hours apart and then at later stage it opens.



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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Gestational age up to 34 6/7 weeks
  2. PDA detected for the first time at less than 14 days of postnatal age
  3. 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.
  4. Platelet count within 24 hours prior to inclusion is less than 100,000 per microliter.

Note: If a platelet count is already available within 24 hours prior to inclusion it will be accepted as a valid platelet count. If not, an urgent absolute platelet count will be performed.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022253


Locations
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India
Post Graduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Study Director: Sourabh Dutta, MD Post Graduate Institute of Medical Education and Research; Chandigarh, India
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sourabh Dutta, Dr, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03022253    
Other Study ID Numbers: INT/IEC/2016/1090
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sourabh Dutta, Postgraduate Institute of Medical Education and Research:
PDA
Platelets
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Acetaminophen
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics