Platelets for Neonatal Transfusion Study 2 (PlaNeT-2):

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Platelets for Neonatal Transfusion Study 2
(PlaNeT-2) A randomised controlled trial of
platelet transfusion thresholds
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Neonatal Thrombocytopenia Current Practice

• Current national transfusion guidance based on
  consensus rather than evidence
• British Committee for Standards in Haematology
  (2004)
• United Kingdom Blood Services (2007)
• Survey in the UK showed wide variation in
  platelet transfusion practice
• Chaudhary and Clarke (2008)

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PlaNeT-2

• Platelets for Neonatal Transfusion - Study 2

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PlaNeT-2 Study design (I)

• Two-stage, randomised, parallel group,
  superiority trial.
• Aim to compare two different platelet count
  thresholds for prophylactic platelet transfusion
  to preterm neonates.
• Primary Outcome
• Proportion of patients who either die or
  experience a major bleed up to and including
  study day 28.

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PlaNeT-2 Study design (II)

• Secondary Outcomes
• Proportion of neonates surviving to home
  following a major bleed
• Mortality prior to day 28
• Major bleeds by day 28
• Platelets transfused to study day 28
• Length of hospital stay
• Transfusion-related adverse events
• Neuro-developmental outcome

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PlaNeT-2 Choosing platelet thresholds

• Last RCT done by Andrew et al (1993) assessed
• 50-150x109/L vs. gt150x109/L
• PlaNeT-1 (2009)
• Most transfusions given at platelets 1050x109/L.
  
• 50th and 90th centile pre-transfusion platelet
  counts 27 and 48x109/L.
• 42 transfusions lt25x109/L and 92 lt50x109/L

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PlaNeT-2 Platelet thresholds

• Arm A Standard transfuse platelets at lt25x109/L
• (330 neonates)
• Arm B Intervention transfuse platelets at
  lt50x109/L
• (330 neonates)
• Dose 15 ml/kg

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PlaNeT-2 Additional platelet transfusions

• May be considered under the following
  circumstances
• Therapeutically to treat moderate, major or
  severe bleeding but not for minor bleeding.
• Prior to planned invasive procedures as below
  only
• Suprapubic aspiration
• Lumbar puncture
• Major surgery where haemostasis may be critical
  to outcome.

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Modified WHO Bleeding Assessment Score
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PlaNeT-2 Inclusion criteria

• Admission to a participating NICU (includes
  postnatal transfers)
• lt34 weeks GA at birth
• Platelet count of lt50 x109/L
• Cranial ultrasound scan undertaken lt6 hours
  before randomisation to exclude recent major IVH

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PlaNeT-2 Exclusion criteria

• Major/life-threatening congenital malformations
• Recent major haemorrhage within the last 72 hours
• All fetal intracranial haemorrhages
• Known immune thrombocytopenia
• Neonates unlikely to survive
• Neonates not given parenteral vitamin K

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PlaNeT-2 Consent
When platelets lt100x109/L
Document on PlaNeT-2 log book
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PlaNeT-2 Randomisation
When the consent is signed and platelets
lt50x109/L
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FA Platelet transfusion information
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F1 Pre-randomisation
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F2 Eligibility for randomisation
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F3 Current medical conditions And previous
major bleeds
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F4 Randomisation
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PlaNeT-2 Data collection (I)
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F5 Bleeding Assessment Tool (BAT)
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F6 Daily Platelet Count
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F7 Weekly Data Collection
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PlaNeT-2 Data collection (II)
F8
F9
F10
F13
F14
F15
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F8 Platelet Transfusion Data
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PlaNeT-2 NEC/Sepsis form

• Necrotising enterocolitis Stage 2 defined as
  per Bells Criteria (Bell et al,1978)
• Sepsis culture positive sepsis or culture
  negative sepsis where a course of at least 5 days
  of antibiotics is to be administered for proven
  or clinically-suspected sepsis.
• All episodes of NEC and sepsis must be recorded
  on the adverse event form
• A listing of adverse events will be reported six
  monthly to the Independent Data Monitoring
  Committee.

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F9 NEC/Sepsis form
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F10 Discontinuation of Treatment Allocation
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PlaNeT-2 Major/Severe bleed form

• All new major bleeding events will be reported to
  the CSU without disclosing allocation arm.
• Each report will be forwarded to the Independent
  Data Monitoring Committee for review as soon as
  it is received at the CSU.
• In cases of uncertainty the local team may
  contact one of the CIs or neonatal medical
  experts.

MAJOR BLEED FORM
Within one working day of becoming aware of an Major Bleed, please fax a completed Major Bleed form to the NHSBT/MRC CSU
Fax [phone]
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F13 Major/Severe Bleed
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PlaNeT-2 Serious Adverse Event (SAE)
A SAE is an adverse event that results

• in death
• is life-threatening
• requires hospitalisation or prolongation of
  existing hospitalisation (including readmission
  within 28 study days if discharged home earlier)
• there is a likelihood of persistent or
  significant disability or incapacity

SAE NOTIFICATION
Within one working day of becoming aware of an SAE, please fax a completed SAE form to the NHSBT/MRC CSU
Fax [phone]
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F14 Serious Adverse Event
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PlaNeT-2 Serious platelet transfusion related
adverse event
Data collected on serious transfusion related
adverse reactions/events will be based on current
definitions used by hospitals reporting to UK
national haemovigilance reporting schemes (SHOT
and MHRA).

• These definitions cover the following
• Incorrect blood component transfused
• Acute transfusion reactions
• Transfusion Related Acute Lung Injury (TRALI)
• Transfusion transmitted infections, including
  bacterial transmission
• Transfusion Associated Circulatory Overload (TACO)

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F15 Serious platelet transfusion related
adverse event
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PlaNeT-2 End of study
Data collection will cease when the baby is 38
weeks corrected gestational age or time of
discharge home
Cranial Ultrasound at End of Study (F11) End of
Study (F12)
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F11 Cranial USS at the end of study
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F12 End of study
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PlaNeT-2 Transfer out of recruiting unit

• Inform the local PlaNeT-2 team if neonate
  transferred out of recruiting unit
• Keep all the forms, do not send them with the
  patient
• If a cranial USS has no been done in the last 7
  days, please perform one before the baby leaves.

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PlaNeT-2 Two years follow up
Thames Regional Perinatal Outcome Group/ Standard
Electronic Neonatal Database/ National Neonatal
Audit Programme (TRPG/SEND/NNAP) 2- year
corrected age outcome form
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PlaNeT-2 Data Quality

• Black ink
• For platelet count use the date and time the
  sample is received in the lab
• Do not leave blank fields, enter leading zeros
• Any data incorrectly recorded must be crossed
  through with a single line and the correct value
  documented by the side. All corrections must be
  initialled and dated by the individual making the
  changes

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PlaNeT-2 Data Quality Cranial USS

• Check what you need to score from the CRFs
• Follow the Units guidelines
• Good quality shot of the right view
• Ask for a second opinion to a senior staff if you
  need
• PlaNeT-2 is a trial based on these USS so that
  all scans are reviewed at local level and
  overseen nationally.

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PlaNeT-2 Communications

• Local queries
• For general trial queries contact Karen
  Willoughby copy Ana Mora.
• For medical queries regarding transfusions, SAEs,
  grading major/severe bleeds or transfusion
  reactions contact Simon Stanworth, Anna Curley or
  Vidheya Venkatesh.

www.planet-2.com
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Two criteria to put a babys sticker in the
PlaNeT-2 book

• Baby born at less than 34 weeks GA
• Platelets lt100

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What is the right documentation of consent?

• Three copies of the consent forms signed.
  Original in site file
• Complete documentation of parental discussion in
  the notes

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Our practice documenting
(Please add here examples of your current
documentation practice)
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If the baby is consented and his platelets go up
to 52 then 51 and then 50 in next three days,
what should you do?
I should wait. As long as the platelet count is
50 or above, the baby can not be randomised.
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Two places where you can find forms

• In the PlaNeT-2 box behind the desk
• Online at www.planet-2.com

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Where are the details to access to
www.sealedenvelope.com?
In the PlaNeT-2 book
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What is wrong with this data collection plan?
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So, is this plan right now?
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Is this a better plan then?
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How can you know at glance what form is due to be
completed?
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CRF Game

• You will be given 4 CRF Forms
• 5 Find 3 sets of mistakes
• 6 - Which two corrections are right?
• 7 - Can you find the two missing fields?
• 9 What is missing?

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Find the three sets of mistakes
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Which two corrections are right?
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Can you find the two missing fields?
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(No Transcript)
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The baby is transferred out of the Unit, three
things you should do

• Inform the PlaNeT-2 team
• Keep all the PlaNeT-2 forms
• A cranial USS if none has been done in the last 7
  days

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Where is the PlaNeT-2 box kept?
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What should you do if an enrolled baby develops a
rectal bleeding?
Inform the PlaNeT-2 team. (A rectal bleeding is
a major bleed that should be reported as soon as
possible)
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What should you do if a SAE happens?

• Proceed as Trust protocol indicates for that
  situation
• Inform the research team as soon as possible

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If you are not sure, what two things you should
do?

• Ask us!! We are here to support you.
• Check on-line www.planet-2.com

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Thank you!