Red Cell Rejuvenation for the Attenuation of Transfusion Associated Organ Injury in Cardiac Surgery

NCT03167788 | Withdrawn Phase 2 DMC

• 1 other identifier: 0582
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 care (unwashed aged stored cells).

Conditions

Organ Failure, Multiple; Inflammation; Sepsis

Outcome Measures

Primary Outcomes (2)

• Renal injury

  measurement of serum creatinine

  baseline to 96 hours postoperatively

• Myocardial injury

  measurement of serum troponin

  baseline to 72 hours postoperatively

Secondary Outcomes (16)

• Protocol compliance measured through protocol deviations

  from date of randomisation through to study completion (3 months)

• Recruitment

  from date of randomisation through to study completion (3 months)

• Event rates

  from date of randomisation through to study completion (3 months)

• Blinding

  from date of randomisation through to study completion (3 months)

• Urinary neutrophil gelatinase associated lipocalin (NGAL)

  baseline to 48 hours postoperatively

Other Outcomes (17)

• Acute lung injury

  from date of randomisation through to study completion (3 months)

• Acute kidney injury

  from date of randomisation through to study completion (3 months)

• Low cardiac output

  from date of randomisation through to study completion (3 months)

Study Arms (2)

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.

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.

Other: Standard Care

Interventions

rejuvesol Solution DEVICE

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.

Intervention

Standard Care OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leicester: lead
• National Health Service, United Kingdom: collaborator
• Zimmer Biomet: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

Department of Cardiovascular Sciences

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

MeSH Terms

Conditions

Multiple Organ Failure; Inflammation; Sepsis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gavin J Murphy, Prof

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 30, 2017
• Study Start: December 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 29, 2021

Record last verified: 2020-05

Locations

GB (1)