Study to Assess S303 RBCs and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia

This study is currently recruiting participants.
Verified April 2013 by Cerus Corporation
Sponsor:
Information provided by (Responsible Party):
Cerus Corporation
ClinicalTrials.gov Identifier:
NCT01716923
First received: October 26, 2012
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Focus:Use of S303 RBCs in Patients With Acute Anemia
Biological: S-303 Red Blood Cells (RBCs) - Test
Biological: Conventional, untreated red blood cells (RBCs) - Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Cerus Corporation:

Primary Outcome Measures:
  • Primary Efficacy Endpoint - mean hemoglobin content [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    The mean hemoglobin content per red blood cell (RBC) component compared between the treatment groups

  • Primary Safety Endpoint - Adverse events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    The frequency of adverse events (related and unrelated to study RBC components) will be compared between the treatment groups.


Secondary Outcome Measures:
  • Secondary Efficacy Endpoint [ Time Frame: Day 35 ] [ Designated as safety issue: No ]
    Proportion of RBC components that have adenosine-5'-triphosphate (ATP) levels of greater than 2 μmol/L

  • Secondary Efficacy Endpoint [ Time Frame: Day 35 ] [ Designated as safety issue: No ]
    Proportion of RBC components that meet the European Union (EU) guideline for hemoglobin content, hematocrit, and hemolysis at the end of storage

  • Secondary Efficacy Endpoint [ Time Frame: Day 35 ] [ Designated as safety issue: No ]
    Proportion of RBC components that have plasma-free hemoglobin levels corresponding to ≤ 0.8% hemolysis


Other Outcome Measures:
  • Exploratory Endpoint - incidence of renal insufficiency [ Time Frame: Daily on days 0 through 6 ] [ Designated as safety issue: No ]
    Incidence of renal insufficiency, indicated by serum creatinine level >2 mg/dL WITH at least a 50% increase from pre-operative baseline OR a new requirement for therapy to treat renal insufficiency (dialysis)

  • Exploratory Endpoint - incidence of hepatic insufficiency [ Time Frame: Daily on days 0 through 6 ] [ Designated as safety issue: No ]
    Incidence of hepatic insufficiency, indicated by total bilirubin that is >2 times the upper limit of normal AND represents at least a 50% increase from the preoperative baseline

  • Exploratory endpoint - Cardiopulmonary function [ Time Frame: Day 7 and 13 ] [ Designated as safety issue: No ]
    Cardiopulmonary function at the time of first ambulation and at the time of discharge, as measured by a standardized 6 Minute Walk Test (6MWT)


Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-303 Treated Red Blood Cells
Patients receive S-303 treated red blood cells (RBCs).
Biological: S-303 Red Blood Cells (RBCs) - Test
Active Comparator: Conventional, untreated Red Blood Cells
Patients receive conventional, untreated red blood cells (RBCs).
Biological: Conventional, untreated red blood cells (RBCs) - Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years, of either gender.
  2. Must be willing to use an acceptable form of contraceptive while on study (as approved by the Investigator or designee)
  3. Must be readily available by telephone
  4. Must provide an informed consent for study participation and have signed an ethics committee (EC)-approved informed consent
  5. Must have a negative cross match to S 303 red blood cells (RBCs) at study entry
  6. Must have a blood type of either A+ or O+
  7. 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
  8. 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.

Exclusion Criteria:

  1. A positive pregnancy test result
  2. Inability of patient to comply with the protocol in the opinion of the Investigator or attending physician
  3. Breast-feeding of an infant or child
  4. Active autoimmune hemolytic anemia, or a positive Direct Antiglobulin Test (DAT) result
  5. Treatment with any medication that is known to adversely affect red blood cell viability
  6. Emergent or salvage surgical status at the time of surgery defined as follows:

    • 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
  7. 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
  8. 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
  9. 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
  10. Pre-existing RBC antibody that may make the provision of compatible study red blood cell (RBC) components difficult
  11. Patients requiring plasma removal or irradiation of the RBC
  12. Patients with prior history of severe allergic transfusion reactions
  13. A positive cross match to S 303 treated RBC

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716923

Contacts
Contact: Arndt H Kiessling, MD 49 69 6301 87015 arndt.kiessling@kgu.de

Locations
Germany
Klinikum der J.-W.-G.-Universität Frankfurt Recruiting
Frankfurt, Germany
Contact: Arndt H Kiessling, MD    49 69 6301 87015    arndt.kiessling@kgu.de   
Principal Investigator: Arndt H Kiessling, MD         
Sponsors and Collaborators
Cerus Corporation
Investigators
Principal Investigator: Arndt H Kiessling, MD Klinikum der J.-W.-G.-Universität Frankfurt
  More Information

No publications provided

Responsible Party: Cerus Corporation
ClinicalTrials.gov Identifier: NCT01716923     History of Changes
Other Study ID Numbers: CLI 00070
Study First Received: October 26, 2012
Last Updated: April 23, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014