1. Trial Procedures and Forms
Dr Richard Francis
STITCH (Trauma) Data Manager

2. Items covered Screening logs How to randomise patients CT scans
Data collection forms
Additional forms

3. Study Flow Chart Diagnostic CT Equipoise Initial Conservative
Consent to STITCH (trauma)
randomise patient
Initial Conservative
Treatment
Early Surgery
5 Days Monitoring
Day 5 CT
Discharge / 2 week form
= things that investigators need to do
6 month outcome questionnaire
12 month outcome questionnaire

4. Screening logs Items Covered How to randomise patients CT scans
Data collection forms
Additional forms

5. Screening Logs Complete each month
Record all Traumatic ICH’s at your centre
Submit to STICH Office by fax or

7. Monthly Screening Log
Tell us why patients
were not suitable

8. Monthly Screening Log
Complete and send
to us in arrears

9. Screening Logs –why do them?
Evidence of centre activity
Useful for planning future studies
Prevents you missing suitable patients!
Encourages you to think about STITCH (Trauma)
Places the study in context of the general characteristics of patients treated in the study centres

11. How to randomise patients
Items Covered
Screening logs
How to randomise patients
CT scans
Data collection forms
Additional forms

12. Check list for recruitment
Does the patient meet the inclusion criteria?
Check CT scan to confirm the diagnosis, size and location of the haematoma.
- Correct any clotting or coagulation problems.
- Check there are no exclusion criteria.
2. Have you obtained informed consent?
Information sheet .
Time to ask questions.
Written witnessed informed consent from
the patient or
the person with the closest personal relationship with the patient who is themselves capable and willing to assent on behalf of the patient.
Copies given to patient and filed in notes and site project file.
3. Have you completed the randomisation form?

13. The scans!

14. SDH
EDH
Cerebellar

15. Complete ALL the data
down to this point

16. Web: https://viis.abdn.ac.uk/HSRU/stitchOR
Call this number

17. The service will allocate:
A randomisation number
The treatment allocation
Write these on the form.
Then return it to the
STITCH (Trauma) office.

18. Telephone Randomisation -Issues
The randomisation service is independent (not STITCH)
In case of problem, try both telephone and web services if possible.
If you still have problems call the STICH Office on +44 (0)
Outside normal office hours a message will give you our emergency number.

19. CT scans Items covered Screening logs How to randomise patients
Data collection forms
Additional forms

20. The scans! Performed pre-randomisation & 5 day
2 different CDs - anonymised – DICOM format
Forward on ASAP in case you lose access to them.

21. Data collection forms Items covered Screening logs CT scans
How to randomise patients
Data collection forms
Additional forms

22. Form types 14 day/ discharge form. 3 month questionnaire
UK Only

23. Two Week / Discharge Form
8 page form
Status at time of completion
Mortality / Disability and GCS
Prior to ICH
Past medical history
Injury details
Anticoagulant / antithrombotic treatment
Treatment
Any Surgery : Evacuation method, Neurological status
Crossovers?
Daily for 5 days post
GCS, limb disability, speech, pupils, temperature.
ICP monitoring
Post-randomisation events – eg stroke

24. Two Week / Discharge Form:
common problems
Eg Page 1
Inconsistent details
Dates missing

25. Eg Page 4
Failure to elaborate

26. Eg Page 5
Failure to describe

27. Eg Page 7
Dates missing

28. What happens after 2 weeks? Non-UK
The STITCH (Trauma) office will contact you at 4/5 and 10 months to confirm:
Is the patient still alive
Their address
Any major adverse events
We will ask you to draft a letter to the patient for us to send with the questionnaires.

29. What happens after 2 weeks? UK only
The STITCH (Trauma) office will contact the patients GP at 2, 4/5 and 10 months to confirm:
Is the patient still alive
Their address
Any major adverse events
We will then draft a letter to the patient to accompany the questionnaires.

30. 6 and 12 Month questionnaires
The STITCH (Trauma) office will usually post these to patients.
Postage is paid by the STITCH (Trauma) office.
It is therefore essential that our investigators help to translate our questionnaires.

31. Your patient
You the investigator
UK Newcastle Office

32. Data Quality and payments
All data forms and scans are checked when received by the STITCH (Trauma) Office
Queries are sent via
Once queries are resolved, payments are initiated!

33. Data Quality and payments
Payment 1 = Randomisation form, CTs and 14 day/ discharge form.
Payment 2 = Questionnaire and major adverse events form for 6 month (+ 3 month if in UK).
Payment 3 = Questionnaire and major adverse events form for 12 month

34. Additional forms Items covered Screening logs CT scans
How to randomise patients
Data collection forms
Additional forms

35. Dates missing

36. Detail

37. One last thing

38. Please respond to e-mails!
One last thing
Please respond to s!

39. Your patient
You the investigator
UK Newcastle Office

40. Your patient
You the investigator
UK Newcastle Office

41. Thank you! Enjoy Newcastle!