Focus:Use of S303 RBCs in Patients With Acute AnemiaPhase 3NCT01716923
Study to Assess S303 RBCs and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia
A Phase 3 study testing S-303 Red Blood Cells (RBCs) - Test in people with Focus:Use of S303 RBCs in Patients With Acute Anemia, run by Cerus Corporation at 2 sites in Germany.
Trial summary
The clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per the European Union (EU) criteria for leukocyte depleted RBCs in additive solution and evaluate the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC transfusion support for acute anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focus:Use of S303 RBCs in Patients With Acute Anemia
- What is being tested?
- S-303 Red Blood Cells (RBCs) - Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2013to Oct 2014
- Phase
- Phase 3
- 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
- Age ≥18 years, of either gender.
- Must be willing to use an acceptable form of contraceptive while on study (as approved by the Investigator or designee)
- Must be readily available by telephone
- Must provide an informed consent for study participation and have signed an ethics committee (EC)-approved informed consent
- Must have a negative cross match to S 303 red blood cells (RBCs) at study entry
- Must have a blood type of either A+ or O+
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- Patients must have a likelihood of receiving a transfusion as determined by the Investigator OR a Transfusion Risk Understanding Screening Tool (TRUST) Score of ≥3 at study entry
- Must be scheduled to receive one of the following operative procedures:
- Coronary artery bypass graft only, first procedure
- Valve repair or replacement only, first procedure
- A combination of first time Coronary Artery Bypass Graft (CABG) and valve repair or replacement
- After consultation with the Medical Monitor, provision can be made to enroll patients who may meet these general criteria but whose surgical procedure is not precisely described in the above categories. Such patients will be classified as "other" with their explicit condition reported with other study data.
Who cannot join
- A positive pregnancy test result
- Inability of patient to comply with the protocol in the opinion of the Investigator or attending physician
- Breast-feeding of an infant or child
- Active autoimmune hemolytic anemia, or a positive Direct Antiglobulin Test (DAT) result
- Treatment with any medication that is known to adversely affect red blood cell viability
- Emergent or salvage surgical status at the time of surgery defined as follows:
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- Presence of ongoing ischemia including angina at rest despite maximal medical therapy
- Acute evolving myocardial infarction within 24 hours before surgery
- Pulmonary edema requiring intubation
- Presence of shock or hemodynamic instability with or without circulatory support
- Systolic blood pressure < 80 mm Hg and/or Cardiac Index < 1.8 despite medical intervention (intravenous inotropes or similar pharmacologic agents)
- Cardiopulmonary resuscitation in the 24 hours prior to surgery or anesthesia induction
- Requiring an intra-aortic balloon pump or ventricular assist device
- Participation in any one of the following types of clinical studies either concurrently or within the previous 28 days: investigational blood products, pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices. Studies of nutrition, psychology, or socioeconomic issues are not grounds for exclusion
- Current diagnosis of either chronic or acute renal failure (requiring dialysis) or a serum creatinine greater than or equal to 1.8 mg/dL within 30 days prior to the start of surgery
- Current diagnosis of either chronic or acute hepatic insufficiency or a total serum bilirubin greater than or equal to 2.0 mg/dL within 30 days prior to the start of surgery
- Pre-existing RBC antibody that may make the provision of compatible study red blood cell (RBC) components difficult
- Patients requiring plasma removal or irradiation of the RBC
- Patients with prior history of severe allergic transfusion reactions
- A positive cross match to S 303 treated RBC
- -
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Kerckhoff-Klinic GmbH
Bad Nauheim, Hesse, 61231
Klinikum der J.-W.-G.-Universität Frankfurt
Frankfurt
About this study
Official title: A Randomized Controlled Double-Blind Phase 3 Study to Assess Characteristics of S 303 Treated RBC Components and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia
The clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per the European Union (EU) criteria for leukocyte depleted RBCs in additive solution and evaluate the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC transfusion support for acute anemia.
- Being tested
- S-303 Red Blood Cells (RBCs) - Test, Conventional, untreated red blood cells (RBCs) - Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-303 Red Blood Cells (RBCs) - TestBiological
Conventional, untreated red blood cells (RBCs) - ControlBiological
| Study group | Role | What they receive |
|---|---|---|
| S-303 Treated Red Blood Cells | Experimental | Patients receive S-303 treated red blood cells (RBCs). Receives: Biological: S-303 Red Blood Cells (RBCs) - Test |
| Conventional, untreated Red Blood Cells | Active comparator | Patients receive conventional, untreated red blood cells (RBCs). Receives: Biological: Conventional, untreated red blood cells (RBCs) - Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint - mean hemoglobin content
The mean hemoglobin content per red blood cell (RBC) component compared between the treatment groups
Measured: Day 2
Primary Safety Endpoint - Adverse events
The frequency of adverse events (related and unrelated to study RBC components) will be compared between the treatment groups.
Measured: 90 days
Secondary outcomes (3)
Secondary Efficacy Endpoint
Proportion of RBC components that have adenosine-5'-triphosphate (ATP) levels of greater than 2 μmol/L
Measured: Day 35
Secondary Efficacy Endpoint
Proportion of RBC components that meet the European Union (EU) guideline for hemoglobin content, hematocrit, and hemolysis at the end of storage
Measured: Day 35
Secondary Efficacy Endpoint
Proportion of RBC components that have plasma-free hemoglobin levels corresponding to ≤ 0.8% hemolysis
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focus:Use of S303 RBCs in Patients With Acute AnemiaStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arndt H Kiessling, MD, Principal investigator, Klinikum der J.-W.-G.-Universität FrankfurtKatharina Madlener, Dr, Principal investigator, Kerckhoff-Klinic GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716923
- Sponsor's protocol ID
- CLI 00070
- Status last verified
- Jun 2015
- First submitted
- 26 Oct 2012
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Brixner V, Kiessling AH, Madlener K, Muller MM, Leibacher J, Dombos S, Weber I, Pfeiffer HU, Geisen C, Schmidt M, Henschler R, North A, Huang N, Mufti N, Erickson A, Ernst C, Rico S, Benjamin RJ, Corash LM, Seifried E. Red blood cells treated with the amustaline (S-303) pathogen reduction system: a transfusion study in cardiac surgery. Transfusion. 2018 Apr;58(4):905-916. doi: 10.1111/trf.14528. Epub 2018 Mar 1.
PubMed 29498049
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Double-Blind Phase 3 Study to Assess Characteristics of S 303 Treated RBC Components and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia
- ClinicalTrials.gov ID
- NCT01716923
- Acronym / sponsor ID
- CLI 00070
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Cerus CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Oct 2012 (estimated)
- 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 clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per the European Union (EU) criteria for leukocyte depleted RBCs in additive solution and evaluate the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC transfusion support for acute anemia.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-303 Treated Red Blood Cells | Experimental | Biological: S-303 Red Blood Cells (RBCs) - TestPatients receive S-303 treated red blood cells (RBCs). |
| Conventional, untreated Red Blood Cells | Active comparator | Biological: Conventional, untreated red blood cells (RBCs) - ControlPatients receive conventional, untreated red blood cells (RBCs). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years, of either gender.
- Must be willing to use an acceptable form of contraceptive while on study (as approved by the Investigator or designee)
- Must be readily available by telephone
- Must provide an informed consent for study participation and have signed an ethics committee (EC)-approved informed consent
- Must have a negative cross match to S 303 red blood cells (RBCs) at study entry
Key exclusion criteria (21 listed)
- A positive pregnancy test result
- Inability of patient to comply with the protocol in the opinion of the Investigator or attending physician
- Breast-feeding of an infant or child
- Active autoimmune hemolytic anemia, or a positive Direct Antiglobulin Test (DAT) result
- Treatment with any medication that is known to adversely affect red blood cell viability
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 |
|---|---|---|
| S-303 Red Blood Cells (RBCs) - Test | Biological | S-303 Treated Red Blood Cells |
| Conventional, untreated red blood cells (RBCs) - Control | Biological | Conventional, untreated Red Blood Cells |
Primary outcome
Primary Efficacy Endpoint - mean hemoglobin content
Time frame: Day 2
The mean hemoglobin content per red blood cell (RBC) component compared between the treatment groups
Primary Safety Endpoint - Adverse events
Time frame: 90 days
The frequency of adverse events (related and unrelated to study RBC components) will be compared between the treatment groups.
3 secondary outcomes
Secondary Efficacy Endpoint
Time frame: Day 35
Secondary Efficacy Endpoint
Time frame: Day 35
Secondary Efficacy Endpoint
Time frame: Day 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Derived from this study: PubMed 29498049Brixner V, Kiessling AH, Madlener K, Muller MM, Leibacher J, Dombos S, Weber I, Pfeiffer HU, Geisen C, Schmidt M, Henschler R, North A, Huang N, Mufti N, Erickson A, Ernst C, Rico S, Benjamin RJ, Corash LM, Seifried E. Red blood cells treated with the amustaline (S-303) pathogen reduction system: a transfusion study in cardiac surgery. Transfusion. 2018 Apr;58(4):905-916. doi: 10.1111/trf.14528. Epub 2018 Mar 1.
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.
Arndt H Kiessling, MD principal investigator
Klinikum der J.-W.-G.-Universität Frankfurt
Katharina Madlener, Dr principal investigator
Kerckhoff-Klinic GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S-303 Red Blood Cells (RBCs) - Test in people with Focus:Use of S303 RBCs in Patients With Acute Anemia, run by Cerus Corporation at 2 sites in Germany.
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 12 inclusion and 21 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: finished, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Efficacy Endpoint - mean hemoglobin content (time frame: Day 2). 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?
On the ClinicalTrials.gov record for NCT01716923, which also lists 1 linked publication.
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 26 Aug 2015.