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05 Oct 2022 Submission of NSA-22

Non-substantial amendment 22 has been submitted to introduce version 7.0 of the information sheets & version 8.0 of the Protocol.

Implementation dates of NSA-22
As a category A amendment, your site has 35 calendar days from the date of this notification to raise an objection about the amendment.

If we do not hear from you by 08 November 2022, we will assume that the amendment may be implemented at your site.

If you need more time to consider the amendment please contact us prior to the 35 day deadline.

If you notify us ahead of the 08 November 2022 date that you are able to accommodate this amendment, it will enable us to implement it sooner.

What is the impact of NSA-22 on research activities & funding?

This amendment does not impact the research activities undertaken at participating NHS organisations, nor does it impact previously been agreed funding or agreements

Please forward us localised copies of v7.0 of the information sheets & as well as the signed investigator page of Protocol v8.0

 

Jan 2022 - Co-enrolment with ABC Sepsis trial, CRYOSTAT-2, HEMOTION, agreed.

 
SA-06 Jan 2022 Patient Info Sheets/Consent Forms & Protocol

All PIS & Guardian/Consultee Info Sheets & Consent Forms, have been revised along with version 7 of the Trial Protocol. Please check the status of implementation of Substantial Amendment 6 with your local R&I teams, and ensure you are using the most recent versions of these documents.

 
ADAPT-Sepsis in Managed Recovery Programme - July 2021

NIHR is working in partnership with research funders, the devolved administrations and other stakeholders in research in a national programme to ensure targeted support enables rapid recovery of selected studies across a range of conditions and builds on the success of research and learnings during the pandemic.

Full guidance available here.

 
ADAPT-Sepsis accepted onto the NIHR's Associate Principal Investigator (PI) Scheme - May 2021

The Associate Principal Investigator (PI) Scheme aims to develop junior doctors, nurses and allied health professionals to become the PIs of the future and provides formal recognition of a trainee's engagement in NIHR Portfolio research studies through the conferment of Associate PI status endorsed by the NIHR and the following medical Royal Colleges:

  • Royal College of Anaesthetists
  • Royal College of Emergency Medicine
  • Royal College of Physicians
  • Royal College of Radiologists
  • Royal College of Surgeons (England)
  • Faculty of Intensive Care Medicine
Click here for the Applicant Registration Form
 
Prof Paul Dark to speak at UKMedlab21 14 - 18 June 2021

He will focus on the evidence underpinning the clinical effectiveness of commonly measurable circulating markers of inflammation and infection in guiding antibiotic stewardship for patients with sepsis.

Areas of uncertainty will be explored, particularly those highlighted during a respiratory viral pandemic, and ongoing multi-centre NHS clinical studies will be reviewed aimed at resolving this uncertainty. The crucial role of NHS clinical biochemistry laboratory services will be highlighted in the co-creation of a new evidence base.

 
Urgent Safety Measure - 3 February 2021

Sites have been made aware of the addition of an exclusion criterion; any patient given, or anticipated to receive an IL-6 receptor inhibitor drug (e.g. tocilizumab or sarilumab) during their acute hospital admission.

Please click on the following; Trial Summary v1, CRF Eligibility v3, Eligibility Criteria Pocket Cards v2 & ADAPT-Sepsis Trial Protocol v5 to see the updated versions of the documents affected by this.

 
Updated Protocol, CRF & Consent Forms available

The latest CRFs and other site documentation is available hereLink opens in a new window.

 
New ADAPT-Sepsis database live

See our new and improved database updated with helpful feedback from sites.

 

We have reached 1000 patients. Thank you to our sites for recruiting patients into this important trial.

ADAPT-Sepsis received Urgent Public Health Badging
ADAPT-Sepsis was badged as an UPH trial on 19-Oct-2020 - for more information on this we have a letter from CI, Prof. Paul Dark to all of our sites
 

 

20 sites open to recruitment with more than 80 patients recruited since reopening

19 ADAPT-Sepsis sites have reopened following the recruitment suspension recruiting a combined 84 patients since the restart in August - taking the overall total patients recruited to 1060.

ADAPT-Sepsis is now open for recruitment

We are delighted to announce ADAPT-Sepsis has received confirmation to restart recruitment. Thank you to all of our recruitment sites for your patience whilst we have prepared for the restart. We very much look forward to working with you again shortly.

The ADAPT-Sepsis trial team will contact each site individually to provide the green light to locally restart recruitment.

Please do not restart screening or recruitment until you have received this greenlight.

Further details of requirements for the restart including refresher training can be found here.Link opens in a new window

All trial documentation for site staff has been uploaded to the website and can be downloaded here.Link opens in a new window

 

Patients recruited: 1,933

Sites Open: 28

The Adapt Sepsis Trial are currently working closely with sites to locally restart recruitment following the COVID 19 pandemic

Click here to view of list of sites.

Enquiries:

Please direct all enquiries to:

Uzma Manazar - Trial Manager
Tel: 02476 151 072
Email: adaptsepsistrial@warwick.ac.uk