MAPS-2 trial
Metoclopramide for Avoiding Pneumonia after Stroke 2


ISRCTN 40512746
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Room S/D2105, Stroke Trials Unit
School of Medicine, University of Nottingham
Queen's Medical Centre, Derby Road
Nottingham NG7 2UH, United Kingdom
History of form changes


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Date CRF / version Details of changes
25 May 2022 Randomisation  v1.1
  • B6: Updated the definition of Definite or probable pneumonia.
Day 14 follow-up  v2.0
  • Added section G: Coenrolment.
  • Added question: C9: Please list any non-serious adverse event that happened from day participant randomised until day 14.
  • Numbering: B4b corrected to B5b.
  • Numbering: B5 corrected to B6.
1 Jul 2022 Randomisation  v1.2
  • B5: Added NIHSS ≥ 6 AND prior to existing text for Dysphagia...
  • Added text: To be eligible, Inclusion criteria B1-B3 must be YES and either B4 or B5 must be YES.
2 Aug 2022 Day 14 follow-up  v2.1
  • Amended title from Trial Day 14 follow-up to Trial Day 14 or Discharge Day assessment.
  • Added A4: Participant status.
  • Added option to E1: mRS, 6- Died.
10 Aug 2022 Randomisation  v1.3
  • Changed B10: eGFR < 30 ml/hour to eGFR < 30 ml/min.
14 Nov 2022 Randomisation  v1.4
  • Changed B16: Removed duplicate has from Has appropriate consent been obtained?
  • Changed F1: Weight (kg) changed label Permitted range 40-200 kg to Permitted range 35-200 kg.
  • Added F4a: Associate PI involved?
  • Added F4b: Name of associate PI.
  • Added Comments.
Daily clinical monitoring log  v1.1
  • Added A3: Participant status.
  • Added Are any values missing due to tests not done (or measures not taken).
  • Added Comments and full explanation for missing data.
Results of cultures  v1.1
  • Added Are any values missing due to tests not done (or measures not taken).
  • Added Comments and full explanation for missing data.
Antibiotic treatment  v1.1
  • Added B5a: Antibiotic status.
  • Added B5b: End date.
  • Added Are any values missing due to tests not done (or measures not taken).
  • Added Comments and full explanation for missing data.
Site-to-site transfer  v1.1
  • Added Are any values missing due to tests not done (or measures not taken).
  • Added Comments and full explanation for missing data.
Discharge to the community  v1.1
  • Added Are any values missing due to tests not done (or measures not taken).
  • Added Comments and full explanation for missing data.
Vital status  v1.1
  • Added Are any values missing due to tests not done (or measures not taken).
  • Added Comments and full explanation for missing data.
Serious Adverse Event  v1.1
  • B6a. Event diagnosis, correct typing mistake.
Pneumonia diagnosis  v1.1
  • Added Are any values missing due to tests not done (or measures not taken).
  • Added Comments and full explanation for missing data.
Day 14 follow-up  v2.2
  • Changed A3: Participant status, added Palliative care.
  • Added D1: Was NIHSS performed within +/- 3 days of day-14 or date of discharge to the community?
  • Added D1a: If NIHSS not performed, please specify reason why.
  • Added D1b: If NIHSS performed prior to day-14/day of discharge, enter date.
  • Added D1c: If full NIHSS break down is not available please give total NIHSS here.
  • Added D13: NIHSS total.
  • Added F1: Was DSRS performed on day-14 or day of discharge?
  • Added F1a: If DSRS not performed, please specify reason why.
  • Added F5: DSRS total
  • Added G1: Was EuroQol 5D-5L performed on day-14 or day of discharge?
  • Added G1a: If EQ-5D-5L not performed, please specify reason why
  • Added G7: EQ-5D-5L total.
  • Added J1. Diagnosis of pneumonia made at any time during day 1-14.
  • Added J1a: If changed, please give details.
  • Added Are any values missing due to tests not done (or measures not taken).
  • Added Comments and full explanation for missing data.
10 Mar 2023 Randomisation  v1.5
  • Changed B3: Onset from 9 hours to 24 hours.
19 Jun 2023 Protocol violation  v1.1
  • Changed B2: Type of protocol violation
  • Changed option 2: Randomisation > 25 hours symptom onset to Randomisation > 25 hours symptom onset
  • Changed option 4: Patient randomised with NIHSS >6, but < 10, without dysphagia to Patient randomised with NIHSS >6, but no dysphagia.
12 Jul 2023 Serious Adverse Event  v1.2
  • Added DO NOT LOCK THE RECORD UNTIL IT HAS BEEN REVIEWED to pending review warning.
  • Added DO NOT LOCK THE RECORD UNTIL IT HAS BEEN UPDATED & REVIEWED to insufficient information warning.
  • Added DO NOT LOCK THE RECORD UNTIL IT HAS BEEN UPDATED & REVIEWED before locking record.
  • B15. Please classify the event, amend options.
  • G3. SAE classification by reviewer, amend options.
  • Section G: CI review, amend label.
3 May 2024 Protocol violation  v1.2
  • Changed B2: Type of protocol violation
  • Changed B2: option 12: Patient randomised whilst co-enrolled in CTIMP without sponsor agreement
  • Added B2: option 19: Incorrect route of trial treatment administration .
Day 14 follow-up  v2.3
  • Added B7a: Did the participant receive any other antiemetics during the trial period?
  • Added B7b: If yes, how many times did the participant receive any other antiemetics during the trial period?.
  • Added B7c: If yes, which antiemetic did the participant receive during the trial period?.
Daily clinical monitoring log  v1.2
  • Added Day number (1-14) and additional dosage.
4 Jun 2024 Serious Adverse Event  v1.3
  • Change Appendix 2 to read Appendix 3
  • On the printed CRF, add Appendix 3
18 Jun 2024 Serious Adverse Event  v1.4
  • Add section G: PI Review
  • Add G1. Reviewed by PI
  • Add G2. I have reviewed and agree with this SAE
  • Add G3. Please enter PI name
  • Add G4. Please sign the form