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NHSBT/MRC Clinical Studies Unit Staying true to the protocol Vidheya Venkatesh NHSBT CTU.

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Presentation on theme: "NHSBT/MRC Clinical Studies Unit Staying true to the protocol Vidheya Venkatesh NHSBT CTU."— Presentation transcript:

1 NHSBT/MRC Clinical Studies Unit Staying true to the protocol Vidheya Venkatesh NHSBT CTU

2 NHSBT/MRC Clinical Studies Unit The Delegation Log GCP training CVs Delineation of roles: consenting training

3 NHSBT/MRC Clinical Studies Unit The Screening log Removal of Patient identifiable data Remember to send monthly

4 NHSBT/MRC Clinical Studies Unit Pre randomisation Excluding major bleed Documenting scan HVP NHSBT Clinical Trials Unit NHSBT CTU

5 NHSBT/MRC Clinical Studies Unit 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 excluded? NHSBT CTU

6 NHSBT/MRC Clinical Studies Unit Who is not excluded? Previous thrombocytopenia Previous transfusions 72 hours after bleed if not actively bleeding Older babies

7 NHSBT/MRC Clinical Studies Unit Passing your data monitoring visit

8 NHSBT/MRC Clinical Studies Unit When platelets <100x10 9 /L Parents will be counselled Written, informed consent will be obtained Documented in the clinical notes Three copies signed: For parents For the clinical notes with Parent Information Sheet For the study file When platelets <50x10 9 /L Parents will be approached for consideration of immediate study participation. Documenting consent Document on PlaNeT-2 log book NHSBT CTU

9 NHSBT/MRC Clinical Studies Unit Documenting randomisation

10 NHSBT/MRC Clinical Studies Unit

11 What is a protocol deviation? When not to give platelets Keeping in the right arm NHSBT Clinical Trials Unit NHSBT CTU

12 NHSBT/MRC Clinical Studies Unit Platelet Transfusion Data (F8) Necrotising enterocolitis (NEC) /Sepsis Form (F9) Discontinuation of Treatment Allocation (F10) Major/Severe Bleed (F13) Serious Adverse Event (F14) Serious Platelet Transfusion Related Adverse Event (F15) The Paperwork F9 F13 F10 F14 F15 F8 NHSBT CTU

13 NHSBT/MRC Clinical Studies Unit F5 – Bleeding Assessment Tool (BAT) NHSBT CTU

14 NHSBT/MRC Clinical Studies Unit Major bleed reporting NHSBT CTU

15 NHSBT/MRC Clinical Studies Unit 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: PlaNeT-2: Major/Severe bleed form

16 NHSBT/MRC Clinical Studies Unit 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 bleed An 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 Modified WHO Bleeding Assessment Score NHSBT CTU

17 NHSBT/MRC Clinical Studies Unit Safety reporting NHSBT Clinical Trials Unit NHSBT CTU

18 NHSBT/MRC Clinical Studies Unit F14 – Serious Adverse Event NHSBT CTU

19 NHSBT/MRC Clinical Studies Unit SAE NOTIFICATION Within one working day of becoming aware of an SAE, please fax a completed SAE form to the NHSBT/MRC CSU Fax: 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 A SAE is an adverse event that results: PlaNeT-2: Serious Adverse Event (SAE)

20 NHSBT/MRC Clinical Studies Unit Adverse events NHSBT CTU

21 NHSBT/MRC Clinical Studies Unit 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. Defining NEC/Sepsis NHSBT CTU

22 NHSBT/MRC Clinical Studies Unit Primary outcome: 28 days 28 day scan NHSBT CTU

23 NHSBT/MRC Clinical Studies Unit End of Study NHSBT CTU

24 NHSBT/MRC Clinical Studies Unit F11 – Cranial USS at the end of study NHSBT CTU

25 NHSBT/MRC Clinical Studies 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. PlaNeT-2: Transfer out of recruiting unit NHSBT CTU

26 NHSBT/MRC Clinical Studies Unit PlaNeT-2: Two year follow up Thames Regional Perinatal Outcome Group/ Standard Electronic Neonatal Database/ National Neonatal Audit Programme (TRPG/SEND/NNAP) 2- year corrected age outcome form NHSBT CTU

27 NHSBT/MRC Clinical Studies Unit Thank you! NHSBT CTU

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