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Effect of red blood cell storage time in pediatric cardiac surgery patients: A subgroup analysis of a randomized controlled trial
Martin, S. M., Tucci, M., Spinella, P. C., Ducruet, T., Fergusson, D. A., Freed, D. H., Lacroix, J., Poirier, N., Sivarajan, V. B., Steiner, M. E., et al
JTCVS open. 2023;15:454-467
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Editor's Choice
Abstract
OBJECTIVE This study aimed to determine whether or not transfusion of fresh red blood cells (RBCs) reduced the incidence of new or progressive multiple organ dysfunction syndrome compared with standard-issue RBCs in pediatric patients undergoing cardiac surgery. METHODS Preplanned secondary analysis of the Age of Blood in Children in Pediatric Intensive Care Unit study, an international randomized controlled trial. This study included children enrolled in the Age of Blood in Children in Pediatric Intensive Care Unit trial and admitted to a pediatric intensive care unit after cardiac surgery with cardiopulmonary bypass. Patients were randomized to receive either fresh (stored ≤7 days) or standard-issue RBCs. The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured up to 28 days postrandomization or at pediatric intensive care unit discharge, or death. RESULTS One hundred seventy-eight patients (median age, 0.6 years; interquartile range, 0.3-2.6 years) were included with 89 patients randomized to the fresh RBCs group (median length of storage, 5 days; interquartile range, 4-6 days) and 89 to the standard-issue RBCs group (median length of storage, 18 days; interquartile range, 13-22 days). There were no statistically significant differences in new or progressive multiple organ dysfunction syndrome between fresh (43 out of 89 [48.3%]) and standard-issue RBCs groups (38 out of 88 [43.2%]), with a relative risk of 1.12 (95% CI, 0.81 to 1.54; P = .49) and an unadjusted absolute risk difference of 5.1% (95% CI, -9.5% to 19.8%; P = .49). CONCLUSIONS In neonates and children undergoing cardiac surgery with cardiopulmonary bypass, the use of fresh RBCs did not reduce the incidence of new or progressive multiple organ dysfunction syndrome compared with the standard-issue RBCs. A larger trial is needed to confirm these results.
PICO Summary
Population
Children admitted to a paediatric intensive care unit after cardiac surgery with cardiopulmonary bypass, enrolled in the Age of Blood in Children in Pediatric Intensive Care Unit trial (ABC-PICU), (n= 178).
Intervention
Fresh (stored ≤7 days) red blood cells (RBCs), (n= 89).
Comparison
Standard-issue RBCs (n= 89).
Outcome
The authors performed a preplanned subgroup analysis of the ABC-PICU trial. The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured up to 28 days post-randomization or at paediatric intensive care unit discharge, or death. There were no statistically significant differences in new or progressive multiple organ dysfunction syndrome between fresh (43 out of 89 [48.3%]) and standard-issue RBCs groups (38 out of 88 [43.2%]), with a relative risk of 1.12; 95% CI [0.81, 1.54] and an unadjusted absolute risk difference of 5.1%; 95% CI [-9.5%, 19.8%].
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A comparative study of stored arterial versus venous blood collected using the acute normovolemic hemodilution method in coronary artery bypass grafting patients in Iran
Mansouri, M., Yazdani, A., Masoumi, G., Mirmohammadsadeghi, M., Mirmohammadsadeghi, A.
Acute and critical care. 2023
Abstract
BACKGROUND In the present study, arterial and venous blood was collected from patients who were candidates for elective coronary artery bypass grafting (CABG); the blood was stored for 28 days and cellular, biomechanical, and hematological changes in blood were compared to determine whether stored arterial blood is superior to stored venous blood. METHODS The present follow-up comparative study included 60 patients >18 years of age, with hemoglobin >14 mg/dl and ejection fraction >40% who were candidates for CABG. After induction of anesthesia, 250 ml of arterial or venous blood was drawn from patients (arterial blood group and venous blood group). Laboratory blood samples were taken at specified times from the collected blood and re-injected into the patients after CABG. RESULTS Significant differences were observed in pH, partial pressure of carbon dioxide (PCO2), partial pressure of oxygen (PO2), bicarbonate (HCO3), and glucose values at several time points between the groups. Other parameters such as urea and creatinine did not show any significant differences between the groups. CONCLUSIONS Twenty-eight days of storage can have a negative effect on some of the cellular, biochemical, and hematological components of arterial and venous blood; however, the quality of stored arterial blood and venous blood does not differ significantly.
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An Individualized Red Blood Cell Transfusion Strategy Using Pediatric Perioperative-Transfusion-Trigger Score Reduced Perioperative Blood Exposure for Children: A Randomized Controlled Clinical Trial
Luo Z, Li Y, Li X, Liao R
Therapeutics and clinical risk management. 2023;19:229-237
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Editor's Choice
Abstract
OBJECTIVE The optimal red blood cell transfusion strategy for children remains unclear. We developed an individualized red blood cell transfusion strategy for children and tested the hypothesis that transfusion guided by this strategy could reduce blood exposure, without increasing perioperative complications in children. METHODS In this randomized controlled clinical trial, 99 children undergoing noncardiac surgeries who had blood loss of more than 20% total blood volume were randomly assigned to an individualized-strategy group using Pediatric Perioperative-Transfusion-Trigger Score or a control group. The amount of transfused red blood cell was counted, and patients were followed up for postoperative complications within 30 days. RESULTS Twenty-six children (53.1%) in the individualized-strategy group received transfusion perioperatively, as compared with 37 children (74%) in the control group (p < 0.05). During surgery, children in the individualized-strategy group were exposed to fewer transfusions than in the control group (0.87±1.03 vs 1.33±1.20 Red-Blood-Cell units per patient, p = 0.02). The incidence of severe complications in the individualized-strategy group had a lower trend compared to the control group (8.2% vs 18%, p = 0.160). No significant difference was found in the other outcomes. CONCLUSION This trial proved that red blood cell transfusion guided by the individualized strategy reduced perioperative blood exposure in children, without increasing the incidence of severe complications. This conclusion needs to be reaffirmed by larger-scale, multicenter clinical trials.
PICO Summary
Population
Children undergoing non-cardiac surgery who had blood loss of more than 20% total blood volume (n= 99).
Intervention
Individualized red blood cell (RBC) transfusion strategy using Pediatric Perioperative-Transfusion-Trigger Score (individualized-strategy group, n= 49).
Comparison
RBC transfusion initiated when the patient’s haemoglobin concentration was lower than 8g per deciliter, or lower than 10g per deciliter for newborns (control group, n= 50).
Outcome
Twenty-six children (53.1%) in the individualized-strategy group received transfusion perioperatively, as compared with 37 children (74%) in the control group. During surgery, children in the individualized-strategy group were exposed to fewer transfusions than in the control group (0.87±1.03 vs. 1.33±1.20 red blood cell units per patient). The incidence of severe complications in the individualized-strategy group had a lower trend compared to the control group (8.2% vs. 18%). No significant difference was found in the other outcomes.
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Autologous versus allogeneic blood transfusion: A comparative study of the peri-operative outcomes in a tertiary care hospital in South India amidst the COVID-19 pandemic
Sam, A. M., Gupta, D., Radhakrishnan, A., Sethuraman, M., Dash, P. K., Pitchai, S., Kesavapisharady, K.
Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis. 2023;:103753
Abstract
Autologous blood transfusion is known to have advantages over allogeneic transfusion. The COVID-19 pandemic intensified the already existing shortage of allogeneic blood supply. We carried out a study during this period with the aim to elicit the effects of autologous blood collection and transfusion, to compare the peri-operative outcomes of autologous and allogeneic transfusion practices and also to assess the influence of the autologous transfusion programme in the Blood Centre inventory. It was prospective observational comparative study among neurosurgical and vascular surgical patients in a tertiary care centre in South India. 141 patients were allocated into Group I (n = 71) who received autologous transfusion and those who received conventional allogeneic transfusion were clustered as Group II (n = 72) for analysis. We employed Acute Normovolemic Hemodilution (ANH), Pre-deposit Autologous Donation (PAD) and Intra-operative Cell Salvage (ICS) as various modalities for autologous blood collection. In our study, 43 (60.6%) from Group I received exclusive autologous blood transfusion, whereas 28 (39.4%) required additional allogeneic transfusion. No significant difference in hemoglobin, hematocrit, platelet count and INR were observed between the groups post transfusion. Significant difference was observed in the thoracoabdominal aortic aneurysm (TAAA) patients with respect to duration of ICU stay (2.7 ± 1.1 days in Group I and 6.2 ± 0.8 days in Group II; p = 0.002) and re-exploration due to bleeding (16.7% in Group I and 40% in Group II; p = 0.048). Autologous blood transfusion is safe and effective. It can be employed as routine practice and also during any acute shortage or pandemic.
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Refraining from Packed Red Blood Cells in Cardiopulmonary Bypass Priming as a Method of Neuroprotection in Pediatric Cardiac Surgery
Ivkin AA, Grigoriev E, Sinitskaya AV
Journal of clinical medicine. 2023;12(4)
Abstract
Congenital heart defect (CHD) surgeries are performed with cardiopulmonary bypass (CPB) and are complicated by several factors that affect the child's brain. However, to date, the number of studies on brain protection in cardiac surgery remains small. The aim of this study was to assess the impact of refraining from using packed red blood cells (PRBCs) in priming solutions in children with congenital defects (CHDs) who require surgical interventions using CPB to prevent brain injury in the postoperative period. MATERIAL AND METHODS This study included 40 children, and the mean age was 14 (12-22.5) months and the mean weight was 8.8 (7.25-11) kg. All patients underwent CHD closure using CPB. The patients were divided into two groups depending on the use of PRBCs in the priming solution. Brain injury was assessed using three specific blood serum markers, namely S100 calcium-binding protein β (S100β), neuron-specific enolase (NSE) and glial fibrillary acidic protein (GFAP) before surgery, after the completion of CPB and 16 h after surgery (first, second and third control points). Markers of systemic inflammatory response were also analyzed, including interleukin-1, -6, -10 and tumor necrosis factor alpha (TNF-α). A clinical assessment of brain injury was carried out using a valid, rapid, observational tool for screening delirium in children of this age group, i.e., "Cornell Assessment of Pediatric Delirium". RESULTS Factors of the intra- and postoperative period were analyzed, such as hemoglobin levels, oxygen delivery (cerebral tissue oxygenation, blood lactate level and venous oxygen saturation) and indicators of organ dysfunction (creatinine, urea, bilirubin levels, duration of CPB and length of stay in the ICU). Following the procedure, there were no significant differences between the groups and all indicators were within the reference values, thus demonstrating the safety of CHD closure without transfusion. Moreover, the highest level of specific markers of brain injury were noted immediately after the completion of CPB in both groups. The concentration of all three markers was significantly higher in the group with transfusion after the completion of CPB. Moreover, GFAP levels were higher in the transfusion group and 16 h after surgery. CONCLUSIONS The results of the study show the safety and effectiveness of brain injury prevention strategies that consist of not conducting PRBC transfusion.
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Individualized red-cell transfusion strategy for non-cardiac surgery in adults: a randomized controlled trial
Liao R, Liu J, Zhang W, Zheng H, Zhu Z, Sun H, Yu Z, Jia H, Sun Y, Qin L, et al
Chinese medical journal. 2023
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Abstract
BACKGROUND Red-cell transfusion is critical for surgery during the peri-operative period; however, the transfusion threshold remains controversial mainly owing to the diversity among patients. The patient's medical status should be evaluated before making a transfusion decision. Herein, we developed an individualized transfusion strategy using the West-China-Liu's Score based on the physiology of oxygen delivery/consumption balance and designed an open-label, multicenter, randomized clinical trial to verify whether it reduced red cell requirement as compared with that associated with restrictive and liberal strategies safely and effectively, providing valid evidence for peri-operative transfusion. METHODS Patients aged >14 years undergoing elective non-cardiac surgery with estimated blood loss > 1000 mL or 20% blood volume and hemoglobin concentration <10 g/dL were randomly assigned to an individualized strategy, a restrictive strategy following China's guideline or a liberal strategy with a transfusion threshold of hemoglobin concentration <9.5 g/dL. We evaluated two primary outcomes: the proportion of patients who received red blood cells (superiority test) and a composite of in-hospital complications and all-cause mortality by day 30 (non-inferiority test). RESULTS We enrolled 1182 patients: 379, 419, and 384 received individualized, restrictive, and liberal strategies, respectively. Approximately 30.6% (116/379) of patients in the individualized strategy received a red-cell transfusion, less than 62.5% (262/419) in the restrictive strategy (absolute risk difference, 31.92%; 97.5% confidence interval [CI]: 24.42-39.42%; odds ratio, 3.78%; 97.5% CI: 2.70-5.30%; P<0.001), and 89.8% (345/384) in the liberal strategy (absolute risk difference, 59.24%; 97.5% CI: 52.91-65.57%; odds ratio, 20.06; 97.5% CI: 12.74-31.57; P<0.001). No statistical differences were found in the composite of in-hospital complications and mortality by day 30 among the three strategies. CONCLUSION The individualized red-cell transfusion strategy using the West-China-Liu's Score reduced red-cell transfusion without increasing in-hospital complications and mortality by day 30 when compared with restrictive and liberal strategies in elective non-cardiac surgeries. TRIAL REGISTRATION ClinicalTrials.gov, NCT01597232.
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Health-related quality of life after restrictive versus liberal RBC transfusion for cardiac surgery: Sub-study from a randomized clinical trial
Hu RT, Royse AG, Royse C, Scott DA, Bowyer A, Boggett S, Summers P, Mazer CD
Transfusion. 2022
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Editor's Choice
Abstract
BACKGROUND Transfusion Requirements in Cardiac Surgery III (TRICS III), a multi-center randomized controlled trial, demonstrated clinical non-inferiority for restrictive versus liberal RBC transfusion for patients undergoing cardiac surgery. However, it is uncertain if transfusion strategy affects long-term health-related quality of life (HRQOL). STUDY DESIGN AND METHODS In this planned sub-study of Australian patients in TRICS III, we sought to determine the non-inferiority of restrictive versus liberal transfusion strategy on long-term HRQOL and to describe clinical outcomes 24 months postoperatively. The restrictive strategy involved transfusing RBCs when hemoglobin was <7.5 g/dl; the transfusion triggers in the liberal group were: <9.5 g/L intraoperatively, <9.5 g/L in intensive care, or <8.5 g/dl on the ward. HRQOL assessments were performed using the 36-item short form survey version 2 (SF-36v2). Primary outcome was non-inferiority of summary measures of SF-36v2 at 12 months, (non-inferiority margin: -0.25 effect size; restrictive minus liberal scores). Secondary outcomes included non-inferiority of HRQOL at 18 and 24 months. RESULTS Six hundred seventeen Australian patients received allocated randomization; HRQOL data were available for 208/311 in restrictive and 217/306 in liberal group. After multiple imputation, non-inferiority of restrictive transfusion at 12 months was not demonstrated for HRQOL, and the estimates were directionally in favor of liberal transfusion. Non-inferiority also could not be concluded at 18 and 24 months. Sensitivity analyses supported these results. There were no differences in quality-adjusted life years or composite clinical outcomes up to 24 months after surgery. DISCUSSION The non-inferiority of a restrictive compared to a liberal transfusion strategy was not established for long-term HRQOL in this dataset.
PICO Summary
Population
Patients undergoing cardiac surgery, enrolled in the Australian cohort of the randomised controlled trial: Transfusion Requirements in Cardiac Surgery III (TRICS III), (n= 617).
Intervention
Restrictive transfusion strategy (n= 311).
Comparison
Liberal transfusion strategy (n= 306).
Outcome
Health-related quality of life (HRQOL) data were available for 208 (67%) patients in the restrictive and 217 (71%) patients in the liberal group. After multiple imputation, non-inferiority of restrictive transfusion at 12 months was not demonstrated for HRQOL, and the estimates were directionally in favor of liberal transfusion. Non-inferiority also could not be concluded at 18 and 24 months. Sensitivity analyses supported these results. There were no differences in quality-adjusted life years or composite clinical outcomes up to 24 months after surgery.
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A physiology-based trigger score to guide perioperative transfusion of allogeneic red blood cells: A multicentre randomised controlled trial
Lu K, Huang Z, Liang S, Pan F, Zhang C, Wei J, Wei H, Wang Y, Liao R, Huang A, et al
Transfusion medicine (Oxford, England). 2022
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Editor's Choice
Abstract
BACKGROUND Restrictive blood transfusion is recommended by major guidelines for perioperative management, but requires objective assessment at 7-10 g/dl haemoglobin (Hb). A scoring system that considers the physiological needs of the heart may simply the practice and reduce transfusion. METHODS Patients (14-65 years of age) undergoing non-cardiac surgery were randomised at a 1:1 ratio to a control group versus a Perioperative Transfusion Trigger Score (POTTS) group. POTTS (maximum of 10) was calculated as 6 plus the following: adrenaline infusion rate (0 for no infusion, 1 for ≤0.05 μg·kg(-1) ·min(-1) , and 2 for higher rate), FiO(2) to keep SpO(2) at ≥95% (0 for ≤35%, 1 for 36%-50%, and 2 for higher), core temperature (0 for <38°C, 1 for 38-40°C, and 2 for higher), and angina history (0 for no, 1 for exertional, and 2 for resting). Transfusion is indicated when actual Hb is lower than the calculated POTTS in individual patients. Transfusion in the control group was based on the 2012 American Association for Blood Banks (AABB) guideline. The primary outcome was the proportion of the patients requiring transfusion of allogeneic red blood cells (RBCs) during the perioperative period (until discharge from hospital), as assessed in the intention-to-treat (ITT) population (all randomised subjects). RESULT A total of 864 patients (mean age 44.4 years, 244 men and 620 women) were enrolled from December 2017 to January 2021 (433 in the control and 431 in the POTTS group). Baseline Hb was 9.2 ± 1.8 and 9.2 ± 1.7 g/dl in the control and POTTS groups, respectively. In the ITT analysis, the proportion of the patients receiving allogeneic RBCs was 43.9% (190/433) in the control group versus 36.9% (159/431) in the POTTS group (p = 0.036). Lower rate of allogeneic RBCs transfusion in the POTTS group was also evident in the per-protocol analysis (42.8% vs. 35.5%, p = 0.030). Transfusion volume was 4.0 (2.0, 6.0) and 3.5 (2.0, 5.5) units (200 ml/unit) in the control and POTTS groups, respectively (p = 0.25). The rate of severe postoperative complications (Clavien-Dindo grade IIIa and higher) was 3.9% in the control group versus 1.2% in the POTTS group (p = 0.010). CONCLUSION Transfusion of allogeneic RBCs based on the POTTS was safe and reduced the transfusion requirement in patients undergoing non-cardiac surgery.
PICO Summary
Population
Patients (14-65 years old) undergoing non-cardiac surgery (n= 864).
Intervention
Transfusion based on a perioperative transfusion trigger score (POTTS), (n= 431).
Comparison
Restrictive transfusion (n= 433).
Outcome
In the intention to treat analysis, the proportion of the patients receiving allogeneic red blood cells (RBCs) was 43.9% (190) in the restrictive group vs. 36.9% (159) in the POTTS group. Lower rate of allogeneic RBCs transfusion in the POTTS group was also evident in the per-protocol analysis (42.8% vs. 35.5%). Transfusion volume was 4.0 (2.0, 6.0) and 3.5 (2.0, 5.5) units (200 ml/unit) in the restrictive and POTTS groups, respectively. The rate of severe post-operative complications was 3.9% in the restrictive group vs. 1.2% in the POTTS group.
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Association Between Length of Storage of Transfused Packed RBC Units and Outcome of Surgical Critically Ill Adults: A Subgroup Analysis of the Age of Blood Evaluation Randomized Trial
Lehr AR, Hébert P, Fergusson D, Sabri E, Lacroix J
Critical care medicine. 2022
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Editor's Choice
Abstract
OBJECTIVES The Age of Blood Evaluation (ABLE) study reported no clinical benefit in fresher compared with standard delivery RBC units (length of storage: 6.9 ± 4.1 vs 22.0 ± 8.4 d, respectively). Perioperative patients are often anemic, at risk of blood loss, and more exposed to RBC transfusions. We address the question whether fresh RBC units are safer than standard delivery RBC units in perioperative ICU patients. DESIGN Subgroup analysis of surgical nontrauma adults enrolled in the ABLE randomized controlled trial. SETTING ICUs. PATIENTS Three hundred twenty surgical patients among the 2,510 ICU adults recruited in the ABLE study who had a request for a first RBC transfusion in the first week in ICU stay and an anticipated length of mechanical ventilation greater than or equal to 48 hours. We included perioperative patients but excluded elective cardiac surgery and trauma. INTERVENTIONS Surgical participants were allocated to receive either RBC units stored less than or equal to 7 days or standard issue RBC. MEASUREMENTS AND MAIN RESULTS The primary outcome was 90-day all-cause mortality.One hundred seventy-two perioperative patients were allocated to the fresh and 148 to the standard group. Baseline data were similar. The length of storage was 7.2 ± 6.4 in fresh and 20.6 ± 8.4 days in standard group (p < 0.0001). The 90-day mortality was 29.7% and 28.4%, respectively (absolute risk difference: 0.01; 95% CI -0.09 to 0.11; p = 0.803). No significant differences were observed for all secondary outcomes, including 6-month mortality, even after adjustment for age, country, and Acute Physiology and Chronic Health Evaluation score. CONCLUSIONS There was no evidence that fresh red cells improved outcomes as compared to standard issue red cells in critically ill surgical patients, consistent with other patients enrolled in the ABLE trial.
PICO Summary
Population
A subgroup of surgical non-trauma patients enrolled in the Age of Blood Evaluation (ABLE) trial (n= 320).
Intervention
Fresh red blood cell (RBC) units (stored less than or equal to 7 days), (n= 172).
Comparison
Standard issue RBC (n= 148).
Outcome
The primary outcome was 90-day all-cause mortality. Baseline data were similar. The length of storage was 7.2 ± 6.4 in fresh and 20.6 ± 8.4 days in standard group. The 90-day mortality was 29.7% and 28.4%, respectively (absolute risk difference: 0.01; 95% CI: -0.09 to 0.11). No significant differences were observed for all secondary outcomes, including 6-month mortality, even after adjustment for age, country, and Acute Physiology and Chronic Health Evaluation score.
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The Effect of Sex-Mismatched Red Blood Cell Transfusion on Endothelial Cell Activation in Critically Ill Patients
Alshalani A, van Manen L, Boshuizen M, van Bruggen R, Acker JP, Juffermans NP
Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie. 2022;49(2):98-105
Abstract
BACKGROUND Observational studies suggest that sex-mismatched transfusion is associated with increased mortality. Mechanisms driving mortality are not known but may include endothelial activation. The aim of this study is to investigate the effects of sex-mismatched red blood cell (RBC) transfusions on endothelial cell activation markers in critically ill patients. STUDY DESIGN AND METHODS In patients admitted to the intensive care unit who received a single RBC unit, blood samples were drawn before (T(0)), 1 h after (T(1)), and 24 h after transfusion (T(24)) for analysis of soluble syndecan-1, soluble intercellular adhesion molecule-1, soluble thrombomodulin (sTM), von Willebrand factor antigen, interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNFα). Changes in the levels of these factors were compared between sex-matched and sex-mismatched groups. RESULTS Of 69 included patients, 32 patients were in the sex-matched and 37 patients were in the sex-mismatched group. Compared to baseline, sex-matched transfusion was associated with significant reduction in sTM level (p value = 0.03). Between-group comparison showed that levels of syndecan-1 and sTM were significantly higher in the sex-mismatched group compared to the sex-matched group at T(24) (p value = 0.04 and 0.01, respectively). Also, TNFα and IL-6 levels showed a statistically marginal significant increase compared to baseline in the sex-mismatched group at T(24) (p value = 0.06 and 0.05, respectively), but not in the sex-matched group. DISCUSSION Transfusion of a single sex-mismatched RBC unit was associated with higher syndecan-1 and sTM levels compared to transfusion of sex-matched RBC unit. These findings may suggest that sex-mismatched RBC transfusion is associated with endothelial activation.