Information for ambulance staff
The PACKMaN trial has now closed to recruitment and follow-up has completed.
Training videos
To access the ambulance staff training videos please select the Training videos tab above or click hereLink opens in a new window.
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On this page you will find the current trial protocol, as well as regulatory approval and information on amendments to the protocol.
Protocol
Approvals and permissions
NIHR ApplicationLink opens in a new window
NIHR ApprovalLink opens in a new window
REC ApprovalLink opens in a new window
HRA ApprovalLink opens in a new window
Amendments
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Substantial amendment #1 - 23rd October 2020
Substantial amendment #1 was at the request of and in agreement with the MHRA following initial approval of the trial. A commitment to submit an amendment to update the IMPD to include intraosseous route of administration for the IMP, and to provide further justification and evidence for this use was a condition of the initial approval.
IRAS Notice of substantial amendment #1Link opens in a new window
SA #1 Amendment toolLink opens in a new window
SA #1 Annex 2Link opens in a new window
SA #1 IO route for administration of IMPLink opens in a new window
SA #1 PACKMaN IMPD v1.1Link opens in a new window
SA #1 Cover letterLink opens in a new window
MHRA approval letter SA#1Link opens in a new window
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Substantial amendment #2 - 11th March 2021
Substantial amendment #2 was to confirm the following:
- Trial team details
- Correct typos, formatting and minor amendments to text,
- Confirm revision to consent process
- Letters to participants and legal representatives and consent forms amended to reflect revised consent process
- Revised Emergency Department (ED) leaflet
- New hospital sites added for the purposes of secondary data collection
SA #2 Amendment tool Link opens in a new window
SA #2 Cover letterLink opens in a new window
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Substantial amendment #3 - 16th March 2021
Substantial amendment #3 was to increase the IMP shelf life to 24 months following the completion of 12 month real-time stability tests.
Note - amendment #3 also includes a non-substantial update to confirm that, as Sponsor for this trial, we have conducted a risk assessment for concomitant use of a COVID-19 vaccine with ketamine, morphine, naloxone and midazolam. Our assessment is that a COVID-19 vaccine given to a trial participant is considered a simple concomitant medication with no interaction that requires advice on timing of the vaccine or other aspects
SA #3 Amendment toolLink opens in a new window
SA #3 Amendment tool: Annex 2Link opens in a new window
PACKMaN IMPD v2.0 15Mar2021Link opens in a new window
MHRA Acknowledgement of amendmentLink opens in a new window
MHRA Notice of acceptance of AmendmentLink opens in a new window
SA #3 Cover letterLink opens in a new window
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Non-substantial amendment #4 - 18th June 2021
Non-substantial amendment #4 includes minor updates to the dosing table in the protocol and minor clarifications to the text in the eConsent forms.
NSA #4 Amendment toolLink opens in a new window
NSA #4 Cover letterLink opens in a new window
NSA #4 HRA approval letterLink opens in a new window
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Substantial amendment #4 - 5th May 2022
Substantial amendment #4 was to update the protocol to clarify an existing exclusion criteria, clarify the follow-up and unblinding process and to permit the enrolment of patients who may be taken to hospitals that have declined trial participation. The PIL has also been updated to include a qualtrics privacy statement.
PACKMaN Protocol v5.0 15Mar2022
SA #4 MHRA Notice of acceptance of Amendment
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Non-substantial amendment #8 - 4th October 2023
Non-substantial amendment #8 includes an update to the end of trial unblinding process and addition of a data sharing agreement in the protocol.
PACKMaN Protocol v6.0 17Aug2023
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Non-substantial amendment #10 - 17th November 2023
Non-substantial amendment #10 includes an update to the TSC PPI members in the protocol.
PACKMaN Protocol v7.0 09Nov2023
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Non-substantial amendment #11 - 25th January 2024
Non-substantial amendment #11 is a minor protocol amendment which provides minor text clarifications for hospital data collection and data retention.
