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• Conditions: Acute anemia secondary to cardiovascular surgery.; MedDRA version: 14.1Level: LLTClassification code 10054312Term: Anemia postoperativeSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2011-006253-29-DE
• Lead Sponsor: Cerus Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-08
• Last Update Posted: 2 September 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

The study will enroll sufficient patients to obtain at least 50 patients with acute anemia who receive at least one RBC component of the assigned treatment type by transfusion during or following an elective cardiac surgery procedure.
In order to minimize the number of patients who enter the study but are not evaluable because they do not receive an RBC transfusion, only patients with a relatively high probability for RBC transfusion will be enrolled. The Transfusion Risk Understanding Screening Tool (TRUST) Score has been validated to predict the likelihood of RBC transfusion in this population. For this study, only patients with a high probability to receive a transfusion as determined by the Investigator OR patients with a TRUST Score of 3 or greater will be eligible for enrollment. The TRUST Score (Alghamdi 2006) is an integer from zero to eight (inclusive); one point is assigned for each of the following elements:
•Hb < 13.5 gm/dL
•Weight < 77 Kg
•Female
•Age > 65 years
•Non-elective surgery
•Serum Cr > 1.36 mg/dL
•Previous cardiac surgery
•Non-isolated surgical procedure
INCLUSION CRITERIA:
1. Must be age 18 years or older
2. Must be willing to use an acceptable form (as approved by the Investigator or designee) of contraception while on study
3. Must be readily available by telephone
4. Must be willing to participate in the second 6MWT at 7 to 10 days after discharge
5. Must provide an informed consent for study participation and have signed an EC-approved informed consent
6. Must have a negative crossmatch to S-303 treated RBCs at study entry
7. Must have a blood type of either A+ or O+
8. Patients must have a likelihood of receiving a transfusion as determined by the Investigator OR a TRUST Score of =3 at study entry
9. 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 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Any of the following criteria will exclude a potential patient from participation in the study:
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 RBC components difficult
11. A positive cross match to S-303 treated RBC

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified