Blood Transfusions and Immune Response | NCT02020525 | Trialant

Blood Transfusions and Immune Response | NCT02020525 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
restrictive transfusion strategy	Experimental	Patients allocated to the restrictive transfusion strategy were transfused only when their hemoglobin concentration decreased below 7.7 g d dL-1 and were then maintained at hemoglobin concentrations between 7.7 and 9.9 g d dL-1.	Procedure: restrictive transfusion strategy
liberal transfusion strategy	Active Comparator	Patients assigned to the liberal strategy were transfused when their hemoglobin concentration fell below 9.9 g dL-1, aiming at maintaining hemoglobin at or above 10 g dL-1.	Procedure: liberal transfusion strategy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
restrictive transfusion strategy	Procedure	Patients allocated to the restrictive transfusion strategy were transfused only when their hemoglobin concentration decreased below 7.7 g d dL-1 and were then maintained at hemoglobin concentrations between 7.7 and 9.9 g d dL-1.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of units transfused per patient as well as the incidence of blood transfusions in each transfusion strategy group (restrictive versus liberal)		first five postoperative days

Secondary Outcomes

Measure	Description	Time Frame
time of initial mobilization postoperatively		first five postoperative days
time of first liquid food intake		first five postoperative days
time of first solid food intake

Other Outcomes

Measure	Description	Time Frame
Secondary post-hoc analysis performed on a subgroup of 20 patients from the original study in order to determine whether there are any differences in the postoperative immunologic response between the two transfusion allocation groups		preoperatively, six, 24 and 72 hours postoperatively

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1393463	Background	Baigrie RJ, Lamont PM, Kwiatkowski D, Dallman MJ, Morris PJ. Systemic cytokine response after major surgery. Br J Surg. 1992 Aug;79(8):757-60. doi: 10.1002/bjs.1800790813.
18354101	Background	Koch CG, Li L, Sessler DI, Figueroa P, Hoeltge GA, Mihaljevic T, Blackstone EH. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008 Mar 20;358(12):1229-39. doi: 10.1056/NEJMoa070403.

Condition Browse Module