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NHSBT CTU. Staying true to the protocol Vidheya Venkatesh. The Delegation Log. GCP training CVs Delineation of roles: consenting training. The Screening log. Removal of Patient identifiable data Remember to send monthly. NHSBT Clinical Trials Unit. NHSBT CTU. Pre randomisation.

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Staying true to the protocol Vidheya Venkatesh

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Staying true to the protocol vidheya venkatesh

NHSBT CTU

Staying true to the protocol

VidheyaVenkatesh


The delegation log

The Delegation Log

  • GCP training

  • CVs

  • Delineation of roles: consenting training


The screening log

The Screening log

  • Removal of Patient identifiable data

  • Remember to send monthly


Pre randomisation

NHSBT Clinical Trials Unit

NHSBT CTU

Pre randomisation

  • Excluding major bleed

  • Documenting scan HVP


Staying true to the protocol vidheya venkatesh

NHSBT CTU

Who is excluded?

  • 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


Who is not excluded

Who is not excluded?

  • Previous thrombocytopenia

  • Previous transfusions

  • 72 hours after bleed if not actively bleeding

  • Older babies


Passing your data monitoring visit

Passing your data monitoring visit


Staying true to the protocol vidheya venkatesh

NHSBT CTU

Parents will be approached for consideration of immediate study participation.

Documenting consent

When platelets <100x109/L

When platelets <50x109/L

Document on PlaNeT-2 log book


Documenting r andomisation

Documenting randomisation


Staying true to the protocol vidheya venkatesh

What is a protocol deviation?

When not to give platelets

NHSBT Clinical Trials Unit

NHSBT CTU

Keeping in the right arm


Staying true to the protocol vidheya venkatesh

NHSBT CTU

The Paperwork

F8

F9

F10

F13

F14

F15


Staying true to the protocol vidheya venkatesh

NHSBT CTU

F5 – Bleeding Assessment Tool (BAT)


Staying true to the protocol vidheya venkatesh

NHSBT CTU

Major bleed reporting


Staying true to the protocol vidheya venkatesh

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.


Modified who bleeding assessment score

NHSBT CTU

Modified WHO Bleeding Assessment Score

  • Grade 1 – Minor Haemorrhage

  • Any bleed from the

    • skin, umbilical cord, skin around stoma, surgical scar, mucosa.

    • Any pink frothy or old bleed from the ET tube.

    • H1 haemorrhage on cranial US (Germinal Layer Haemorrhage, GLH)

  • Grade 2 – Moderate Haemorrhage

  • Any frank bleed from

    • the stoma

    • macroscopic haematuria,

    • IVH (H2 or H3) without dilatation (V0),

    • Acute fresh bleed through ETT without ventilatory changes

  • Grade 3 – Major Haemorrhage any:

    • Frank Rectal

    • Acute fresh bleed through ETT with ventilatory change.

    • Intracranial bleedAn intracranial bleed is defined as a major bleed if any of the following apply: Neurosurgical intervention is required; Scans show a midline shift; Clinical signs and symptoms of neurolgical deficit with significant derangement of laboratory investigations

    • Major IVH is defined as 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)

  • Grade 4 – Severe Haemorrhage

    • Shock defined as life threatening major bleed associated with hypotension, hyopovolaemia or any other haemodynamic instability and/or bleeding requiring volume boluses, red cell transfusion in the same 24 hours, fatal major bleeding


Safety reporting

NHSBT Clinical Trials Unit

NHSBT Clinical Trials Unit

NHSBT Clinical Trials Unit

NHSBT CTU

Safety reporting


Staying true to the protocol vidheya venkatesh

NHSBT CTU

F14 – Serious Adverse Event


Staying true to the protocol vidheya venkatesh

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


Staying true to the protocol vidheya venkatesh

NHSBT CTU

Adverse events


Staying true to the protocol vidheya venkatesh

NHSBT CTU

Defining NEC/Sepsis

  • 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.


Staying true to the protocol vidheya venkatesh

NHSBT CTU

Primary outcome: 28 days

28 day scan


Staying true to the protocol vidheya venkatesh

NHSBT CTU

End of Study


Staying true to the protocol vidheya venkatesh

NHSBT CTU

F11 – Cranial USS at the end of study


Staying true to the protocol vidheya venkatesh

NHSBT CTU

PlaNeT-2:Transfer out of recruiting unit

  • Inform the local PlaNeT-2 team if neonate transferred out of recruiting unit

  • Use transfer pack

  • Receiving hospital should:

    • Collect information as required by the protocol thereafter until 38 weeks CGA or discharge.


Staying true to the protocol vidheya venkatesh

NHSBT CTU

Thank you!


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