Cerebral Blood FlowNCT05775263
Validation of UK Protocols to Exclude Brain Blood Flow During Normothermic Regional Perfusion (NRP)
An observational study of Cerebral Blood Flow, run by Papworth Hospital NHS Foundation Trust.
Trial summary
This study aims to evaluate both Abdominal Normothermic Regional Perfusion (A-NRP) and Thoracoabdominal-NRP (TA-NRP) techniques, proving that brain blood flow is not resumed during NRP. This will be assessed through the use of two modalities: CT angiogram of the brain and continuous Hb02 readings. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Blood Flow
- What is being tested?
- CT angiogram
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Donation after Circulatory Death (DCD) organ donors
Who may be able to join
- DCD donors in Cambridge University Hospital
- Planned A-NRP
- Consent for study has been obtained
- Those who meet the appropriate criteria for DCD donation following WOLST
- ≥ 18 years of age
- ≤ 75 years of age
Who cannot join
- DBD organ donors
- DCD organ donations outside of Cambridge University Hospital
- DCD donors without planned A-NRP
- DCD donors whose family have withheld consent for brain blood flow investigations.
- Patients who do not meet the appropriate criteria for DCD donation following WOLST
- Patients with injuries that will physically prevent use of the necessary assessment methods
Trial locations and contacts
No sites are listed yet.
Thomas Howlett contact
About this study
This study aims to evaluate both Abdominal Normothermic Regional Perfusion (A-NRP) and Thoracoabdominal-NRP (TA-NRP) techniques, proving that brain blood flow is not resumed during NRP. This will be assessed through the use of two modalities: CT angiogram of the brain and continuous Hb02 readings. The study group hypothesise that such assessment methods will provide evidence to indicate that brain blood flow is not present during NRP and promote trust in the use of such novel techniques in routine practice.
- Conditions
- Cerebral Blood Flow
- Being tested
- CT angiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT angiogramProcedure or surgery
CT angiography of the brain 30 minutes from establishment of NRP
| Study group | Role | What they receive |
|---|---|---|
| A-NRP | Not described Receives: Procedure: CT angiogram | |
| TA-NRP | Not described Receives: Procedure: CT angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT angiogram
Brain blood flow
Measured: 30 minutes from establishment of NRP
Secondary outcomes (1)
Cerebral oximetry
HbO2 measurements (O2Hbi (Delta oxygenated), HHbi (Delta deoxygenated), and cHbi (Delta total))
Measured: Prior to withdrawal of life sustaining treatment to 30 minutes after establishment of NRP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Jun 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Blood FlowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775263
- Sponsor's protocol ID
- PO3027
- Status last verified
- Nov 2023
- First submitted
- 7 Mar 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of UK Protocols to Exclude Brain Blood Flow During Normothermic Regional Perfusion (NRP)
- ClinicalTrials.gov ID
- NCT05775263
- Acronym / sponsor ID
- PO3027
- Conditions
- Cerebral Blood Flow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate both Abdominal Normothermic Regional Perfusion (A-NRP) and Thoracoabdominal-NRP (TA-NRP) techniques, proving that brain blood flow is not resumed during NRP. This will be assessed through the use of two modalities: CT angiogram of the brain and continuous Hb02 readings. The study group hypothesise that such assessment methods will provide evidence to indicate that brain blood flow is not present during NRP and promote trust in the use of such novel techniques in routine practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-NRP | – | Procedure: CT angiogram |
| TA-NRP | – | Procedure: CT angiogram |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Donation after Circulatory Death (DCD) organ donors
Key inclusion criteria (6 listed)
- DCD donors in Cambridge University Hospital
- Planned A-NRP
- Consent for study has been obtained
- Those who meet the appropriate criteria for DCD donation following WOLST
- ≥ 18 years of age
Key exclusion criteria (6 listed)
- DBD organ donors
- DCD organ donations outside of Cambridge University Hospital
- DCD donors without planned A-NRP
- DCD donors whose family have withheld consent for brain blood flow investigations.
- Patients who do not meet the appropriate criteria for DCD donation following WOLST
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT angiogramCT angiography of the brain 30 minutes from establishment of NRP | Procedure or surgery | A-NRP, TA-NRP |
Primary outcome
CT angiogram
Time frame: 30 minutes from establishment of NRP
Brain blood flow
1 secondary outcome
Cerebral oximetry
Time frame: Prior to withdrawal of life sustaining treatment to 30 minutes after establishment of NRP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Howlett contact
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Blood Flow, run by Papworth Hospital NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Rubino (01223 639574, a.rubino@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT angiogram (time frame: 30 minutes from establishment of NRP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.