SvO2 Trigger in Transfusion Strategy After Cardiac Surgery (NCT02761564) | Clinical Trial Compass
CompletedNot Applicable
SvO2 Trigger in Transfusion Strategy After Cardiac Surgery
France100 participantsStarted 2016-10-06
Plain-language summary
Current international guidelines suggest a restrictive transfusion strategy, setting that Hb level at 7 g/dl is a reasonable threshold. However, the idea of having only one threshold for all the patients has been challenged by authors, suggesting a more liberal strategy for certain cases. At the moment, there is no other parameter considered accurate enough to be taken into consideration for transfusion strategy management.
This study is to use ScVO2, a current, easily accessible parameter, before blood transfusion in order to stratify its indication after cardiac surgery.
Monocentric, randomised, single blind study (patient not aware of the group assignments) Patient inclusion will be made in ICU if the physician decides to perform blood transfusion according to standard transfusion strategy to treat a postoperative anemia (Hb\<9g/dL).
Every patient will go through randomization to be placed in one of the two groups of the study: either the one whose transfusion strategy is adjusted by the pretransfusion ScvO2 (group ScvO2), or the control group.
Our main objective is to evaluate the impact of a new transfusion strategy founded on guidelines, but provided ScvO2 is less than 65%, on the incidence of red blood cells transfusion for anemia early after cardiac surgery.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age over 18 years
* Patients admitted to intensive care after heart surgery
* Anemic patient (Hb \< 9 g/dL)
* Patient with a central venous catheter in the territory SVC
Exclusion Criteria:
* Patient with acute bleeding defined as a postoperative bleeding over 1000 ml in 12 hours or the need for a recovery operation for hemostasis or the transfusion of blood units over 4
* Patient with severe sepsis or septic shock criteria defined by the Surviving Sepsis compaign
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a measurement called ScVO2 — oxygen levels in blood from a central venous catheter — to decide when to give a blood transfusion after cardiac surgery; is that kind of monitoring something that would be used in my care, and how does it compare to the standard way transfusion decisions are usually made?
2The trial focused on patients who had anemia after cardiac surgery with hemoglobin below 9g/dL — if my hemoglobin drops to that level after my operation, what criteria would my care team use to decide whether I actually need a transfusion?
3Since this trial has already been completed and was measuring how many patients ended up needing a transfusion, has the data from it changed any of the transfusion guidelines your team follows for cardiac surgery patients?
4The trial only included patients who were hemodynamically and respiratorily stable after surgery — if I become unstable after my operation, does that mean a completely different transfusion approach would be used, and what would that look like?
5Blood transfusions after cardiac surgery can carry their own risks — based on what this trial and other research have shown, how does my care team weigh the risks of transfusing against the risks of leaving post-surgical anemia untreated in my specific situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.