This trial is comparing two different platelet transfusion thresholds and aims to establish whether a lower platelet transfusion threshold is as good as a higher threshold.

Study definitions and FAQs


Definitions for Major and Severe Bleeding:

Major Bleed:

  • Frank rectal defined as macroscopic faecal bleed (not if only occult positive).
  • Pulmonary bleed defined as acute fresh bleed through the ETT associated with increased ventilatory requirements or the need for intubation and ventilation.

An intracranial bleed is defined as a major bleed if any of the following apply:

  • Neurosurgical intervention is required
  • Radiological imaging showing a midline shift
  • Clinical signs and symptoms of neurological deficit with significant derangement of laboratory investigations.

An IVH is defined as a major bleed if any of the following apply:

  • H2 or H3 with ventricular dilatation (V1)
  • H1, H2, H3 with parenchymal involvement (P3)
  • Any evolution of intracranial haemorrhage to H2V1, H3V1, or (H1, H2, H3) with parenchymal involvement (P3)


Severe Bleed
:

Severe bleed or shock is defined as life threatening major bleed associated with hypotension, hypovolaemia or any other haemodynamic instability and/or bleeding requiring volume boluses or red cell transfusion in the same 24 hours.


Grading for Cranial Ultrasound

Grading

P0

H0

V0

NONE

P0

H0

V1

NONE

P0

H1

V0

MINOR

P0

H1

V1

MODERATE

P0

H2

V0

MODERATE

P0

H2

V1

MAJOR

P0

H3

V0

MODERATE

P0

H3

V1

MAJOR

P1

H0

V0

MINOR

P1

H0

V1

MINOR

P1

H1

V0

MINOR

P1

H1

V1

MODERATE

P1

H2

V0

MODERATE

P1

H2

V1

MAJOR

P1

H3

V0

MODERATE

P1

H3

V1

MAJOR

P2

H0

V0

MODERATE

P2

H0

V1

MODERATE

P2

H1

V0

MODERATE

P2

H1

V1

MODERATE

P2

H2

V0

MODERATE

P2

H2

V1

MAJOR

P2

H3

V0

MODERATE

P2

H3

V1

MAJOR

P3

H0

V0

MAJOR

P3

H0

V1

MAJOR

P3

H1

V0

MAJOR

P3

H1

V1

MAJOR

P3

H2

V0

MAJOR

P3

H2

V1

MAJOR

P3

H3

V0

MAJOR

P3

H3

V1

MAJOR

If Cranial USS indicates a major bleed, please complete ‘Major Bleed’ Forms 13a, 13b & 13c and fax to NHSBT within 24 hours of identification of the event

Click here to download a copy of our FAQs

Frequently Asked Questions

Q1 What does PlaNet 2 stand for ?

A. It stands for Platelet for Neonatal Transfusion - study 2 which follows on from a prospective multicentre observational study of platelet transfusion practice in neonates. (PlaNeT 1)

Q2 Which babies can be admitted in PlaNet 2?
A. Babies less than 34 weeks gestation are eligible to enter the study.

Q3 What is the primary outcome of this study and why did we choose day 28 for primary outcome?
A. To measure the proportion of patients who either die or experience a major bleed up to and including study day 28. Twenty eight days was chosen because the PlaNeT 1 study showed the majority of bleeds occurred before 28 days of life.

Q4 What are the secondary outcomes of PlaNeT 2?
A. There are a few secondary outcomes including :
a) Measuring the proportion of patients who are going to be discharged home with or without a bleed.
b) See protocol for detailed secondary outcomes.

Q5 If a baby has a platelet count of 101 can we include the baby in pre randomisation?
A. No, the cut off is less than 100.

Q6 What do we have to do in pre randomisation?
A. We have to counsel parents and provide them with an information leaflet, and to complete the screening log. We need to discuss consent at this stage.

Q7 Can we wait for this till the next day?
A. No, we need to do it the same day as platelets may drop to the randomisation category from pre randomisation.

Q8 What are the two platelet transfusion thresholds in PlaNet2?
A. In Arm A babies will receive a platelet transfusion once the count is < 25. In Arm B babies will receive a transfusion once the count is < 50.

Q9 If the baby's platelets go up to 52 then 51 and then 50 in next three days, what should you do?
A. As long as the platelet count is above 50, the baby can not be randomised.

Q10 The baby now has platelets of 48, what is the next step?
A. The baby will go in to the randomisation process provided informed consent has been given by the parents / guardians.

Q11 Is there anything else we have to do at that time?
A. Make sure the consent has been taken from the parents or guardian BEFORE randomisation. We need to make sure that the baby has a baseline cranial ultrasound in the 6 hours prior to randomisation. If not, please proceed to one or ask your colleague to do one immediately.

Q12 Is it important to have a cranial ultrasound of all participant neonates prior to the study?

if yes , please explain the timing of performing it.
A. All participants must have a cranial ultrasound prior to study. Each centre must have the capability to conduct cranial USS at any time, 24 hours a day. Cranial USS required are as follows:
a) Within 6 hours prior to randomisation
b) Thereafter, a minimum of weekly USS (+/-3 days) should be performed until study day 28 or prior to discharge if earlier
c) For neonates who remain in hospital longer than 28 days, any scan performed should be recorded in the weekly assessment form and a final USS should be done prior to discharge.

Q13 What are the three important points not to be missed while performing a cranial ultrasound scan in those patients and where we are going to record the findings?
A. The data to be collected from the USS reports and recorded in the bleeding assessment tool / weekly assessment forms (to be completed as per accompanying guidance notes) are as follows:
Evidence of intracranial haemorrhage and its extent
Ventricular Size
Parenchymal injury and grade.

Q14 What randomisation tool will be used in this trial?
A. A web-based randomisation service provided by (http//:www.sealedenvelope.com) accessible by each participating centre will be used. It will allocate neonates using minimisation with a random element.

Q15 What will happen after randomisation?
A. Babies will be randomly assigned into one of two arms of treatment (see Q8).

Q16 What is the platelet transfusion volume in mls/kg for the study. Will there be any dose difference in prescribing platelets between two arms?
A. The platelet transfusion dose is 15mls/kg per transfusion. Both arms will receive the same prescribing dose.

Q17 What are the possibilities of early withdrawal of the treatment allocation?
A. If in the clinical judgement of the attending clinician, an enrolled neonate cannot follow treatment allocation (e.g. a higher platelet transfusion is clinically warranted), the case should be discussed with the joint chief investigator or one of the medical experts.
Irrespective of the clinical decision, data collection should continue, aiming to complete data collection at least up to study 28. Reason for deviation from the randomised treatment allocation should also be recorded.

Q18 Will there be any restriction in administering other medications or blood products during the trial period?
A. No, any clinically indicated medication and blood products are permitted during the time the patient is in the PlaNet-2 trial. There are no restrictions on concomitant medications.

Q19 What will happen if a baby is still inpatient after day 14?
A. In infants who are inpatients after study day 14, daily data collection will cease and a weekly data collection form will then be started and continued until the time of discharge home or 38 weeks corrected gestational age.

Q20 What will happen once thrombocytopenia has resolved?
A. The observation of the participant will continue regardless of whether the neonate's thrombocytopenia has resolved or whether the neonate has further episodes of thrombocytopenia.

Q21 What will happen if further thrombocytopenic episodes develop post study day 28?
A. After randomisation, allocation will apply for the entire inpatient stay, including for neonates that develop new episodes of thrombocytopenia after study day 14, until the time of discharge home or at 38 weeks corrected gestational age.
For further episode of thrombocytopenia, daily bleeding assessment forms are not required after study day 14 even if thrombocytopenia recurs. Therefore only weekly assessment forms needs to be completed.

Q22 What will you do if the baby's platelet count is < 50 x 100 9 /L after day 14 of study?
A. It is envisaged that there will be sufficient daily bleeding assessment data on these neonates for detailed analysis and comparison with other patient groups. Therefore daily data collection will stop at this point as with neonates whose platelet count has recovered. Data collection will continue weekly until discharge.

Q23 What will happen to those neonates who are transferred out of the participating unit and who will be responsible in liaising with staff of other units?
A. A log will be kept of neonates transferred out of a participating unit to another unit. For such neonates the receiving hospital will be requested to complete the weekly assessment forms and to perform a cranial USS on study day 28 (+/- 3days), as required by the protocol thereafter until 38 Weeks CGA or discharge.
The Trial Manager will be responsible for liaising with the staff in the other units to remind them to do this.

Q24 What will happen to those neonates who are discharged home from a participating unit?
A. Data collection will cease and an End of Study Form will be completed at the time of discharge home, or at 38 weeks corrected gestational age.

Q25 How are we going to undertake two year neuro-developmental follow up?
A. Neuro-developmental follow-up will be undertaken by validated Thames Regional Perinatal Outcome Group/ Standard Electronic Neonatal Database/ National Neonatal Audit Programme (TRPG/SEND/NNAP) 2- year corrected age outcome form and will be administered at 2 years of corrected gestational age.
The results of the WHO functional disability criteria and any disability will be classified into 3 groups: mild, moderate and severe. A record of all deaths within 2 years after randomisation will be kept.

Q26 What are the contact details and timeframes for safety reporting?
A. Within one working day of becoming aware of a safety event (Major / Severe Bleed, Serious Adverse Event), please fax a completed form to the NHSBT/MRC CSU Fax: 01223 588136.

Q27 What are Serious Adverse Events (SAE) in this trial?
A. 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)
results in persistent or significant disability or incapacity.