Organ Failure, MultiplePhase 2NCT03167788
Red Cell Rejuvenation for the Attenuation of Transfusion Associated Organ Injury in Cardiac Surgery
A Phase 2 study testing rejuvesol Solution in people with Organ Failure, Multiple and Inflammation, run by University of Leicester at 1 site in United Kingdom.
Trial summary
The REDJUVENATE Trial proposes to test the hypothesis that postoperative organ injury and inflammation will be less if patients undergoing cardiac surgery who are at risk of large volume blood transfusion (defined as the administration of ≥4 units of red cells) receive rejuvenated washed cells compared to standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Failure, Multiple, Inflammation, Sepsis
- What is being tested?
- rejuvesol Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2020to Dec 2020
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult cardiac surgery patients (≥18 years) undergoing cardiac surgery with cardiopulmonary bypass.
- Identified as representing a high risk group for massive blood transfusion using a modified risk score. A large volume blood transfusion (LVBT) score of >23 indicates predicted risk of receiving ≥4 units of allogeneic red cells equal to or greater than 55 per cent.
Who cannot join
- Emergency or salvage procedure
- Patients with end stage renal failure defined as an estimated Glomerular Filtration rate (eGFR) <15 mL/min/1.72 m2 calculated from the Modification of Diet in Renal Disease equation, or patients who are on long-term haemodialysis or have undergone renal transplantation.
- Patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah's Witnesses).
- Patients with a pre-existing sepsis or organ injury defined as documented sepsis, acute kidney injury, acute lung injury, myocardial infarction, low cardiac output, liver injury, stroke or pancreatitis within 5 days of surgery.
- Pregnancy.
- Patients who are participating in another interventional clinical study.
- Patients requiring irradiated blood.
- Sickle cell anaemia.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Cardiovascular Sciences
Leicester, Leicestershire, LE3 9QP
About this study
Official title: A RANDOMISED CONTROLLED TRIAL OF RED CELL REJUVENATION FOR THE ATTENUATION OF TRANSFUSION ASSOCIATED ORGAN INJURY IN CARDIAC SURGERY: The REDJUVENATE Trial
The REDJUVENATE Trial proposes to test the hypothesis that postoperative organ injury and inflammation will be less if patients undergoing cardiac surgery who are at risk of large volume blood transfusion (defined as the administration of ≥4 units of red cells) receive rejuvenated washed cells compared to standard care (unwashed aged stored cells).
Read the detailed description
In the REDJUVENATE trial, we propose to establish whether the administration of rejuvenated red cells will reduce inflammation and organ injury in cardiac surgery patients at risk of large volume blood transfusion when compared to standard care. Organ injury and sepsis accounts for the majority of all deaths following cardiac surgery. Once organ injury is established care is primarily supportive and there are no effective treatments. Prevention is therefore a key clinical strategy to prevent death, morbidity and high healthcare costs attributable to these complications. Sepsis and inflammatory organ injury are also the principal causes of death following paediatric cardiac surgery, trauma, non-cardiac complex surgical procedures and in critical care; clinical settings that are also among the principal consumers of blood components. National and international blood management strategies are focused on these patients. Evidence of a clinical benefit attributable to the use of rejuvenated red cells in cardiac surgery patients is therefore likely to translate into more widespread benefits to patients and the National Health Service (NHS).
- Conditions
- Organ Failure, Multiple, Inflammation, Sepsis
- Being tested
- rejuvesol Solution, Standard Care
- Medical subject headings
- Multiple Organ Failure, Inflammation, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rejuvesol SolutionDevice
The rejuvenation process involves incubation of stored red cells with a rejuvenating solution, rejuvesol Red Blood Cell Processing Solution (rejuvesol® Solution), Citra labs, MA, a Zimmer Biomet Company, IN, USA) which restores red cell adenosine triphosphate (ATP), 2,3-DPG (diphosphoglycerate), oxygen transfer characteristics and rheology. Post rejuvenation red cells are washed to remove the rejuvesol Solution, and cells are re-suspended in additive solution for transfusion.
Standard CareOther
Allogeneic red cells, harvested in citrate-phosphate-dextrose (CPD), leucocyte depleted, saline-adenine-glucose-mannitol (SAGM) stored red cell units, issued by National Health Service Blood \& Transplant (NHSBT) will be administered to cardiac surgery patients as per standard practice, and according to established unit protocols.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Cross-matched allogeneic stored red cells will be rejuvenated using rejuvesol® Red Blood Cell Processing Solution (Citra Labs, MA, a Zimmer Biomet Company, IN, USA) with washing and re-suspension in an additive solution prior to transfusion. The rejuvenated red cells will then be administered to the patient as per standard practice and according to established institutional protocols. A maximum of 6 rejuvenated red cell units will be transfused within any 24 hour period. Receives: Device: rejuvesol Solution |
| Control | Active comparator | Standard care i.e. Cross-matched allogeneic stored non-rejuvenated, unwashed red cells will be administered to the patient as per standard practice and according to established institutional protocols. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal injury
measurement of serum creatinine
Measured: baseline to 96 hours postoperatively
Myocardial injury
measurement of serum troponin
Measured: baseline to 72 hours postoperatively
Secondary outcomes (16)
Protocol compliance measured through protocol deviations
protocol deviations will be aggregated based on pre-defined codes
Measured: from date of randomisation through to study completion (3 months)
Recruitment
measured through recruitment figures
Measured: from date of randomisation through to study completion (3 months)
Event rates
measured through serious adverse event (SAE)/ serious unexpected serious adverse reaction (SUSAR) reporting
Measured: from date of randomisation through to study completion (3 months)
Blinding
measured through protocol deviations
Measured: from date of randomisation through to study completion (3 months)
Urinary neutrophil gelatinase associated lipocalin (NGAL)
measured through urine collection
Measured: baseline to 48 hours postoperatively
Serum creatinine
measured to assess renal function
Measured: at 6 weeks postoperatively
eGFR
measured to assess renal function
Measured: at 6 weeks postoperatively
Sepsis-related Organ Failure Assessment (SOFA) Score
Sepsis will be defined as suspected or documented infection and an acute change in total SOFA score ≥2 points consequent to the infection.
Measured: at baseline, 24, 48, 72 and 96 hours postoperatively
Arterial serum lactate
Measured: 24 hours postoperatively until time of resolution of hyperlactataemia
Lung injury
arterial alveolar oxygen ratios
Measured: baseline to 96 hours postoperatively
GI tract injury
serum amylase and liver function tests
Measured: at baseline, 24, 48, 72, and 96 hours postoperatively
Transfusion reactions
measured as part of standard care to assess transfusion safety
Measured: from date of randomisation through to study completion (3 months)
Age of each unit of red cells transfused
Measured: day of operation
Postoperative blood loss, transfusion of red cell and non-red cell allogenic blood components
Measured: day of operation
Adverse events other than those included in the primary endpoint
Measured: from date of randomisation through to study completion (3 months)
Length of ICU and hospital stay
Measured: from date of randomisation through to study completion (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study startDec 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Manufacturing Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ Failure, MultipleStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom, Zimmer Biomet, British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Gavin J Murphy, Prof, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167788
- Sponsor's protocol ID
- 0582
- Status last verified
- May 2020
- First submitted
- 12 May 2017
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMISED CONTROLLED TRIAL OF RED CELL REJUVENATION FOR THE ATTENUATION OF TRANSFUSION ASSOCIATED ORGAN INJURY IN CARDIAC SURGERY: The REDJUVENATE Trial
- ClinicalTrials.gov ID
- NCT03167788
- Acronym / sponsor ID
- 0582
- Conditions
- Organ Failure, Multiple, Inflammation, Sepsis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Manufacturing Issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom, Zimmer Biomet, British Heart Foundation
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 May 2017 (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.
The REDJUVENATE Trial proposes to test the hypothesis that postoperative organ injury and inflammation will be less if patients undergoing cardiac surgery who are at risk of large volume blood transfusion (defined as the administration of ≥4 units of red cells) receive rejuvenated washed cells compared to standard care (unwashed aged stored cells).
Detailed description
In the REDJUVENATE trial, we propose to establish whether the administration of rejuvenated red cells will reduce inflammation and organ injury in cardiac surgery patients at risk of large volume blood transfusion when compared to standard care. Organ injury and sepsis accounts for the majority of all deaths following cardiac surgery. Once organ injury is established care is primarily supportive and there are no effective treatments. Prevention is therefore a key clinical strategy to prevent death, morbidity and high healthcare costs attributable to these complications. Sepsis and inflammatory organ injury are also the principal causes of death following paediatric cardiac surgery, trauma, non-cardiac complex surgical procedures and in critical care; clinical settings that are also among the principal consumers of blood components. National and international blood management strategies are focused on these patients. Evidence of a clinical benefit attributable to the use of rejuvenated red cells in cardiac surgery patients is therefore likely to translate into more widespread benefits to patients and the National Health Service (NHS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: rejuvesol SolutionCross-matched allogeneic stored red cells will be rejuvenated using rejuvesol® Red Blood Cell Processing Solution (Citra Labs, MA, a Zimmer Biomet Company, IN, USA) with washing and re-suspension in an additive solution prior to transfusion. The rejuvenated red cells will then be administered to the patient as per standard practice and according to established institutional protocols. A maximum of 6 rejuvenated red cell units will be transfused within any 24 hour period. |
| Control | Active comparator | Other: Standard CareStandard care i.e. Cross-matched allogeneic stored non-rejuvenated, unwashed red cells will be administered to the patient as per standard practice and according to established institutional protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult cardiac surgery patients (≥18 years) undergoing cardiac surgery with cardiopulmonary bypass.
- Identified as representing a high risk group for massive blood transfusion using a modified risk score. A large volume blood transfusion (LVBT) score of >23 indicates predicted risk of receiving ≥4 units of allogeneic red cells equal to or greater than 55 per cent.
Key exclusion criteria (8 listed)
- Emergency or salvage procedure
- Patients with end stage renal failure defined as an estimated Glomerular Filtration rate (eGFR) <15 mL/min/1.72 m2 calculated from the Modification of Diet in Renal Disease equation, or patients who are on long-term haemodialysis or have undergone renal transplantation.
- Patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah's Witnesses).
- Patients with a pre-existing sepsis or organ injury defined as documented sepsis, acute kidney injury, acute lung injury, myocardial infarction, low cardiac output, liver injury, stroke or pancreatitis within 5 days of surgery.
- Pregnancy.
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 |
|---|---|---|
| rejuvesol SolutionThe rejuvenation process involves incubation of stored red cells with a rejuvenating solution, rejuvesol Red Blood Cell Processing Solution (rejuvesol® Solution), Citra labs, MA, a Zimmer Biomet Company, IN, USA) which restores red cell adenosine triphosphate (ATP), 2,3-DPG (diphosphoglycerate), oxygen transfer characteristics and rheology. Post rejuvenation red cells are washed to remove the rejuvesol Solution, and cells are re-suspended in additive solution for transfusion. | Device | Intervention |
| Standard CareAllogeneic red cells, harvested in citrate-phosphate-dextrose (CPD), leucocyte depleted, saline-adenine-glucose-mannitol (SAGM) stored red cell units, issued by National Health Service Blood \& Transplant (NHSBT) will be administered to cardiac surgery patients as per standard practice, and according to established unit protocols. | Other | Control |
Primary outcome
Renal injury
Time frame: baseline to 96 hours postoperatively
measurement of serum creatinine
Myocardial injury
Time frame: baseline to 72 hours postoperatively
measurement of serum troponin
16 secondary outcomes
Protocol compliance measured through protocol deviations
Time frame: from date of randomisation through to study completion (3 months)
Recruitment
Time frame: from date of randomisation through to study completion (3 months)
Event rates
Time frame: from date of randomisation through to study completion (3 months)
Blinding
Time frame: from date of randomisation through to study completion (3 months)
Urinary neutrophil gelatinase associated lipocalin (NGAL)
Time frame: baseline to 48 hours postoperatively
Serum creatinine
Time frame: at 6 weeks postoperatively
eGFR
Time frame: at 6 weeks postoperatively
Sepsis-related Organ Failure Assessment (SOFA) Score
Time frame: at baseline, 24, 48, 72 and 96 hours postoperatively
Arterial serum lactate
Time frame: 24 hours postoperatively until time of resolution of hyperlactataemia
Lung injury
Time frame: baseline to 96 hours postoperatively
GI tract injury
Time frame: at baseline, 24, 48, 72, and 96 hours postoperatively
Transfusion reactions
Time frame: from date of randomisation through to study completion (3 months)
Age of each unit of red cells transfused
Time frame: day of operation
Postoperative blood loss, transfusion of red cell and non-red cell allogenic blood components
Time frame: day of operation
Adverse events other than those included in the primary endpoint
Time frame: from date of randomisation through to study completion (3 months)
Length of ICU and hospital stay
Time frame: from date of randomisation through to study completion (3 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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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.
Gavin J Murphy, Prof principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rejuvesol Solution in people with Organ Failure, Multiple and Inflammation, run by University of Leicester at 1 site in United Kingdom.
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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal injury (time frame: baseline to 96 hours postoperatively). The study lists 2 primary outcomes in all. 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 29 Apr 2021.