REd CEll Storage Duration Study (RECESS)

Study ID
STU 102010-057

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Kenni Landgraf
214-645-8087
kenni.landgraf@utsouthwestern.edu

Principal Investigator
Philip Greilich

Summary

Patients 18 years of age or older scheduled to undergo complex cardiac surgery will be screened using the Transfusion Risk understanding Scoring Tool (TRuST - range 0-8). Those with a TRuST score [GreaterThanorequalTo]3 will be enrolled (if consent is obtained). Subjects will be randomized the day prior to surgery if suitable units of required RBCs are available. The two treatment arms are transfusion with RBC stored [LessThanorequalTo]10 days vs. RBC stored [GreaterThanorequalTo]21 days. an evaluable subject is one that requires transfusion of at least one unit of RBC.

The primary outcome variable is the multiple organ dysfunction score (MoDS - range 0-24). This a composite scoring system based on respiratory function (P02/Fi02 ratio), renal function (serum creatinine), hepatic function (serum bilirubin), cardiovascular function (pressure-adjusted heart rate), hematologic competency (platelet count) and neurologic function (Glascow coma scope). The change in MoDS value ([?]MoDS) will be calculated by summing the worst individual component scores (0-4) for each of the systems up until post-operative Day 7, hospital discharge, or death then substracting this score from the MoDS determined immediately prior to surgery.

The primary study endpoint is post-operative Day 7, hospital discharge, or death, whichever occurs first. The secondary endpoints are up to post-operative Day 28, hospital discharge, or death, whichever occurs first.

MaRS
MaRS is an ancillary study to ReCeSS, and it will create a pedigreed biorepository of donor and recipient RBC samples plus recipient plasma and PBMC samples from subjects in the ReCeSS trial.

We expect to enroll up to 250 subjects who are randomized in the ReCeSS study and undergo cardiac surgery. ReCeSS subjects who receive RBC transfusions during surgery, or in the following 96 hours, will have blood samples drawn at 5 time points: Day 0, 2, 6, 28, and optional 180. ReCeSS subjects who do not receive RBC transfusions during this time period will have blood samples drawn on Day 0 and Day 2. We will also collect samples from an additional 50 healthy volunteers. in this MaRS project we intend to perform laboratory tests and analyze data from 120 randomized ReCeSS subjects who receive RBC transfusions (60 from each treatment arm), 50 randomized ReCeSS subjects who undergo cardiac surgery but do not receive RBC transfusions, and 50 healthy, non-ReCeSS volunteers (recruited only at Blood Systems Research institute, BSRi) . These subjects, and the remaining MaRS subjects, will all contribute samples to the repository that could be used for potential future testing.

no additional randomization will be carried out for subjects in MaRS.

Participant Eligibility

1) Patients >=18 years old
2) Patients >=40 kg
3) Scheduled complex cardiac surgery with planned use of median sternotomy. The procedure
may be performed either on-pump or off-pump. Procedures that qualify as complex cardiac
surgery include the following (
* Repeat procedure
* means that the subject had a previous
cardiac surgery with median sternotomy.):

* Single Vessel Coronary Artery Bypass Graft, repeat procedure

* Multiple Coronary Artery Bypass Grafts, first or repeat procedure

* Single Valve Repair or Replacement, repeat procedure

* Multiple Valve Repair or Replacement, first or repeat procedure

* Surgery involving both Coronary Artery Bypass Graft(s) and Valve Repair(s), first or
repeat procedure

* One or more of the following procedures, with or without Coronary Bypass Graft(s):

* left ventricular aneurysm repair,

* ventricular and/or atrial septal defect repairs,

* batista (surgical ventricular remodeling),

* surgical ventricular restoration,

* congenital defect repair, and

* aortic root procedures
4) Patients >=18 years must have a TRUST (Alghamdi) probability score >=3, which corresponds to
a high likelihood of receiving RBC transfusions during surgery or within 96 hours post
operatively (see Appendix 1 of protocol). Calculate the TRUST score using the most recent
test results done within the previous 60 days. If data for some components of the TRUST
score are not available, but enough data are available to know that the TRUST score is at least
3, the patient meets this eligibility criterion.