scholarly journals Factor VIII inhibitor bypass activity (FEIBA) for the reduction of transfusion in cardiac surgery: a randomized, double-blind, placebo-controlled, pilot trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Valerie A. Sera ◽  
Ann E. Stevens ◽  
Howard K. Song ◽  
Victor M. Rodriguez ◽  
Frederick A. Tibayan ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Prothrombin Complex Concentrate ◽  
Rescue Therapy ◽  
Circulatory Arrest ◽  
Pilot Trial ◽  
Factor Viii Inhibitor ◽  
Bleeding Diathesis ◽  
Blood Products ◽  
Protocol Adherence ◽  
Transfusion Requirements

Abstract Background Uncontrolled bleeding after cardiac surgery can be life-threatening. Factor eight inhibitor bypassing activity (FEIBA) is a prothrombin complex concentrate empirically used as rescue therapy for correction of refractory bleeding diathesis post-cardiopulmonary bypass (CPB). FEIBA used as rescue therapy for bleeding diathesis after CPB has been associated with a low incidence of complications and a reduction in transfusion requirement and re-exploration. The feasibility and efficacy of early administration of FEIBA after the termination of CPB have not been studied in a prospective randomized trial. Methods We designed a small randomized, double-blinded, placebo-controlled pilot trial to determine the feasibility of a larger trial testing the hypothesis that FEIBA decreases transfusion requirements after CPB. The study was designed to evaluate the feasibility of a larger pivotal trial to determine the effectiveness of FEIBA in reducing the total volume of blood products transfused perioperatively, and its safety profile. Study participants were adult patients undergoing elective major aortic cardiovascular surgery at a tertiary referral hospital, who were equally randomized to receive a single dose of either FEIBA or matched placebo intraoperatively at the end of CPB. Results Twenty patients were screened and 12 were randomized and included in the analysis. Protocol adherence was high, and all patients received the study drug per intention-to-treat except one patient. There were no protocol deviations or events of unblinding, and adverse events were not different between groups. Patients in the FEIBA group were older and more likely to be female and had higher BMI, lower hematocrit, and longer hypothermic circulatory arrest. There were no differences in post-randomization blood product transfusions (difference FEIBA vs. placebo −899 mL; 95% CI −5206 to 3409) or in the administration of open-label FEIBA. Conclusions This pilot trial confirmed the adequacy of the trial design that involved the early, blinded administration of FEIBA, by demonstrating excellent protocol adherence. We conclude that a larger trial establishing the effectiveness of early prothrombin complex concentrate administration to reduce the use of blood products in the setting of high-risk cardiac surgery is feasible. Trial registration ClinicalTrials.gov, NCT02577614. Registered 16 October 2015

scholarly journals Factor VIII Inhibitor Bypass Activity (FEIBA) for the Reduction of Transfusion in Cardiac Surgery: A Randomized, Double-Blind, Placebo-controlled, Pilot Trial

2020 ◽  
Author(s):  
Valerie A Sera ◽  
Ann E Stevens ◽  
Howard K Song ◽  
Victor M Rodriguez ◽  
Frederick A Tibayan ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Prothrombin Complex Concentrate ◽  
Rescue Therapy ◽  
Circulatory Arrest ◽  
Pilot Trial ◽  
Factor Viii Inhibitor ◽  
Bleeding Diathesis ◽  
Blood Products ◽  
Double Blind ◽  
Transfusion Requirements

Abstract BackgroundUncontrolled bleeding after cardiac surgery can be life threatening. Factor eight inhibitor bypassing activity (FEIBA) is a prothrombin complex concentrate empirically used as rescue therapy for correction of refractory bleeding diathesis post cardiopulmonary bypass (CPB). FEIBA use as rescue therapy for bleeding diathesis after CPB has been associated with a low incidence of complications and a reduction in transfusion requirement and re-exploration. The feasibility and efficacy of early administration of FEIBA after termination of CPB have not been studied.MethodsWe designed a small randomized, double-blinded, placebo-controlled pilot trial to determine the feasibility of a larger trial testing the hypothesis that FEIBA decreases transfusion requirements after CPB. Twelve adult patients undergoing elective major aortic cardiovascular surgery at a tertiary referral hospital were equally randomized to receive a single dose of either FEIBA or matched placebo intraoperatively at the end of CPB. The study was designed to evaluate the feasibility of a larger pivotal trial to determine the effectiveness of FEIBA in reducing the total volume of blood products transfused perioperatively, and its safety profile.ResultsThere were no protocol deviations or events of unblinding, and adverse events were not different between groups. Patients in the FEIBA group were older, more likely to be female, had higher BMI, lower hematocrit, and longer hypothermic circulatory arrest. There were no differences in post randomization blood product transfusions (difference FEIBA vs. placebo: -899 mL; 95%CI: -5,206 to 3,409, p=0.65).ConclusionsThis pilot trial confirmed the adequacy of the trial design that involved the early, blinded administration of FEIBA, by demonstrating excellent protocol adherence. We conclude that a larger trial establishing the effectiveness of early prothrombin complex concentrate administration to reduce the use of blood products in the setting of high-risk cardiac surgery is feasible. Trial RegistrationClinicalTrials.gov NCT02577614, Registered 16 October, 2015, https://clinicaltrials.gov/ct2/show/NCT02577614

scholarly journals Factor VIII Inhibitor Bypass Activity (FEIBA) for the Reduction of Transfusion in Cardiac Surgery: A Randomized, Double-Blind, Placebo-Controlled, Pilot Trial

2020 ◽  
Author(s):  
Valerie A Sera ◽  
Ann E Stevens ◽  
Howard K Song ◽  
Victor M Rodriguez ◽  
Frederick A Tibayan ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Prothrombin Complex Concentrate ◽  
Rescue Therapy ◽  
Circulatory Arrest ◽  
Pilot Trial ◽  
Factor Viii Inhibitor ◽  
Bleeding Diathesis ◽  
Blood Products ◽  
Double Blind ◽  
Transfusion Requirements

Abstract Background Uncontrolled bleeding after cardiac surgery can be life threatening. Factor eight inhibitor bypassing activity (FEIBA) is a prothrombin complex concentrate empirically used as rescue therapy for correction of refractory bleeding diathesis post cardiopulmonary bypass (CPB). FEIBA use as rescue therapy for bleeding diathesis after CPB has been associated with a low incidence of complications and a reduction in transfusion requirement and re-exploration. The feasibility and efficacy of early administration of FEIBA after termination of CPB have not been studied.Methods We designed a small randomized, double-blinded, placebo-controlled pilot trial to determine the feasibility of a larger trial testing the hypothesis that FEIBA decreases transfusion requirements after CPB. Twelve adult patients undergoing elective major aortic cardiovascular surgery at a tertiary referral hospital were equally randomized to receive a single dose of either FEIBA or matched placebo intraoperatively at the end of CPB. The study was designed to evaluate the feasibility of a larger pivotal trial to determine the effectiveness of FEIBA in reducing the total volume of blood products transfused perioperatively, and its safety profile.Results There were no protocol deviations or events of unblinding, and adverse events were not different between groups. Patients in the FEIBA group were older, more likely to be female, had higher BMI, lower hematocrit, and longer hypothermic circulatory arrest. There were no differences in post randomization blood product transfusions (difference FEIBA vs. placebo: -899 mL; 95%CI: -5,206 to 3,409, p = 0.65).Conclusions This pilot trial confirmed the adequacy of the trial design that involved the early, blinded administration of FEIBA, by demonstrating excellent protocol adherence. We conclude that a larger trial establishing the effectiveness of early prothrombin complex concentrate administration to reduce the use of blood products in the setting of high-risk cardiac surgery is feasible.Trial Registration: ClinicalTrials.gov Identifier: NCT02577614

scholarly journals Effects of implementing rotational thromboelastometry in cardiac surgery: A retrospective cohort study

2021 ◽  
pp. 175045892095066
Author(s):  
Minna Kallioinen ◽  
Mika Valtonen ◽  
Marko Peltoniemi ◽  
Ville-Veikko Hynninen ◽  
Tuukka Saarikoski ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Prothrombin Complex Concentrate ◽  
Fresh Frozen Plasma ◽  
Blood Products ◽  
Rotational Thromboelastometry ◽  
Number Of Patients ◽  
Fresh Frozen ◽  
The Mean ◽  
To Receive ◽  
Frozen Plasma

Since 2013, rotational thromboelastometry has been available in our hospital to assess coagulopathy. The aim of the study was to retrospectively evaluate the effect of thromboelastometry testing in cardiac surgery patients. Altogether 177 patients from 2012 and 177 patients from 2014 were included. In 2014, the thromboelastometry testing was performed on 56 patients. The mean blood drainage volume decreased and the number of patients receiving platelets decreased between 2012 and 2014. In addition, the use of fresh frozen plasma units decreased, and the use of prothrombin complex concentrate increased in 2014. When studied separately, the patients with a thromboelastometry testing received platelets, fresh frozen plasma, fibrinogen and prothrombin complex concentrate more often, but smaller amounts of red blood cells. In conclusion, after implementing the thromboelastometry testing to the practice, the blood products were given more cautiously overall. The use of thromboelastometry testing was associated with increased possibility to receive coagulation product transfusions. However, it appears that thromboelastometry testing was mostly used to assist in management of major bleeding.

scholarly journals Transfusion Requirements in Anemic Patients undergoing Cardiac Surgery

2017 ◽  
Vol 2 (1) ◽  
pp. 26-27
Author(s):  
Vaishali S Badge ◽  
Henry Skinner
Keyword(s):  
Cardiac Surgery ◽  
Morbidity And Mortality ◽  
Surgical Patients ◽  
Transfusion Rate ◽  
Allergic Reactions ◽  
Blood Products ◽  
Transfusion Requirements

ABSTRACT Cardiac surgery is one of the largest consumer of blood and blood products in medicine. The transfusion rate in cardiac surgery accounts to almost 40-90%. Although lifesaving, it still increases the risk of allergic reactions, risk of transmission of infection, increased morbidity and mortality. The aim of this study was to find out causes of anaemia and requirement of blood or blood products in cardiac surgical patients. How to cite this article Badge VS, Skinner H. Transfusion Requirements in Anemic Patients undergoing Cardiac Surgery. Res Inno in Anesth 2017;2(1):26-27.

Abstracts for the British Congenital Cardiac Association Annual Meeting: The Barbican, London, 24–25 November 2005: Oral Presentations: Perioperative red cell salvage in paediatric cardiac surgery

2006 ◽  
Vol 16 (3) ◽  
pp. 316-316
Author(s):  
S. Salam ◽  
D. Abrams ◽  
A. Kelleher ◽  
J. La Rovere
Keyword(s):  
Cardiac Surgery ◽  
Blood Transfusion ◽  
Red Blood Cells ◽  
Blood Cells ◽  
Red Cell ◽  
Infectious Agents ◽  
Cell Salvage ◽  
Blood Products ◽  
Potential Health ◽  
Transfusion Requirements

Objective: In recent years blood transfusion has become a debated health care issue. To minimise exposure to infectious agents and reduce bank blood transfusion requirements, leucocyte filtration and perioperative red cell salvage (RCS) are increasingly used in paediatric patients. We hypothesised RCS would reduce the need for additional blood products in children following cardiopulmonary bypass (CPB). Methods: Patients undergoing routine or emergency cardiac surgery requiring CPB over a study period of 3 months were included prospectively in the analysis. Haemoglobin, platelet count, coagulation screen and heparin levels were performed before, immediately after surgery and 24 hours later. RCS was performed in theatre according to surgical and anaesthetic preference. Red cells were salvaged from the surgical site, anticoagulated, washed and following resuspension in saline reinfused into the patient within 4 hours. The incidence of post-operative bleeding (>10 ml/kg/hr) was recorded, as was the need for additional red blood cells, platelets and fresh frozen plasma (FFP). The need for blood products was at the discretion of the consultant intensivist. Statistical analysis was performed using student t-test and Chi squared methods. Significance was accepted as p < 0.05. Results: Thirty-five consecutive patients (34.54 ± 43.55 months, 13.48 ± 14.39 kg) were included in the analysis. A total of 17 infants <12 months were included, 9/24 who received RCS and 8/11 who did not (p 0.052). Cyanotic heart disease was seen in 40%. RCS was performed in 24 of 35 patients, who were significantly older (44.2 ± 44.1 vs. 13.6 ± 25.5, p 0.02) and heavier (16.6 ± 16.2 vs. 6.7 ± 4.7, p 0.01). No difference was seen in the prevalence of cyanosis between the two groups. Post-operative bleeding was seen in 21% who underwent RCS and 40% in those who did not (p 0.33). The need for additional red blood cells was significantly reduced in those who received RCS, 37.5% vs. 91%, p 0.003, as was the use of FFP, 8.3% vs. 45.5%, p 0.02. There was no difference in the need for platelet transfusion, p 0.2. Discussion: In this study RCS was performed on 68.5% of children following CPB. RCS significantly reduced the need for further blood and FFP transfusion, although this was not related to post-operative bleeding. This has important implications for both exposure to infectious agents and health economics. That children who underwent RCS were older and heavier may be related to the complexity of surgery and CPB in younger patients, although infants were represented in both groups. A further analysis of potential health and economic benefits in a homogenous group is needed.

Use of blood products in cardiac surgery

Perfusion ◽  
1997 ◽  
Vol 12 (3) ◽  
pp. 157-162 ◽  
Author(s):  
M C Renton ◽  
D BL McClelland ◽  
C J Sinclair
Keyword(s):  
Cardiac Surgery ◽  
Cell Mass ◽  
Red Cell ◽  
Blood Products ◽  
Elective Cardiac Surgery ◽  
Transfusion Requirements ◽  
Red Cell Mass ◽  
The Face ◽  
Preoperative Factors ◽  
Cardiac Operations

The quantity of blood products used perioperatively during cardiac surgery is known to vary widely between institutions. This study looked at the amount of blood products used perioperatively in 74 consecutive elective cardiac operations in one institution. The results are compared with those from other European centres and a cost analysis carried out. On average 2.33 ± 0.74 (95% confidence interval 1.93-2.77) units of red cell concentrate were transfused perioperatively per patient. Six (8%) patients received no blood products. In addition a number of preoperative factors were studied in an attempt to identify predictors of transfusion requirements. Age, preoperative haemoglobin, female sex and red cell mass were all found to have some predictive value. In the face of increasing demands on a limited supply of blood products we question the need for crossmatching more than four units of red cell concentrate in elective cardiac surgery.

Transfusion Managament in Cardiac Surgery in British Columbia: Review of 8352 Patients.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2277-2277
Author(s):  
Maha A Badawi ◽  
Kate M Chipperfield
Keyword(s):  
Risk Factors ◽  
British Columbia ◽  
Cardiac Surgery ◽  
Mortality Data ◽  
Published Data ◽  
Fisher Exact Test ◽  
Blood Products ◽  
Specific Patient ◽  
Significant Variability ◽  
Transfusion Requirements

Abstract Abstract 2277 Background: Transfusion of blood products remains an essential intervention during hospitalization for cardiac surgeries. Published data reveal significant variability in the patterns of transfusion of blood products among different centers. In addition, published data suggest that allogenic transfusions are associated with worse outcomes in cardiac surgery patients. This project was conducted to investigate for significant variability in transfusion practices in the management of cardiac surgery patients in the 4 cardiac surgery centers within the province of British Columbia (BC). Secondary objectives include assessing for correlation of specific patient and surgical characteristics with risk of transfusion, in addition to comparing one-year mortality in patients who received transfusions with those who did not. Methods: A retrospective review of data collected through the BC Cardiac Registry (BCCR) was performed. All adult patients who underwent cardiac surgery in BC between January 1,2008 to December 31,2010 were included. The following patients were excluded: Jehovah's witnesses, heart transplantation recipients and patients who underwent aortic aneurysm repair not including aortic valve surgery. In patients who underwent more that one surgery within 365 days, data were only collected for the first cardiac surgery. The following data were collected: age, gender, type of surgery, clinical urgency, institution, preoperative hemoglobin, preoperative eGFR, duration of cardio-pulmonary bypass and use of cell saver technology. Mortality data over 1 year post operatively and quantities of packed red blood cells (PRBCs), frozen plasma (FP), platelets and cryoprecipitate (cryo) transfused during surgery and within 30 days afterwards were also collected. Cardiac surgery centers were anonymized. Chi-square test and Fisher exact test were used to analyze variation in transfusion requirements. Kaplan-Meir curves will be created for estimation of survival. Multivariate regression analysis will be used to identify risk factors for transfusion. Results: After excluding patients as outlined above, 8352 patients were included in the analysis. A summary of transfusion rates of different blood products in different types of cardiac surgeries among different centers is summarized in table 1. Statistical analysis is currently in progress to assess for association between transfusion of blood products and survival, in addition to multivariate analysis to identify risk factors for transfusion. Conclusions: Significant differences are noted in transfusion requirement of PRBCs, FP and platelets during and within 30 days of cardiac surgery among the four different cardiac surgery centers in British Columbia. The differences are not accounted for by surgery type alone. Further research is required to identify factors to account for the observed variability. Consideration will be made for development of further measures for standardization of transfusion management in this patient group. Disclosures: No relevant conflicts of interest to declare.

The Effect of Desmopressin on Reducing Blood Loss in Cardiac Surgery – A Meta-Analysis of Double-Blind, Placebo-Controlled Trials

1995 ◽  
Vol 74 (04) ◽  
pp. 1064-1070 ◽  
Author(s):  
Marco Cattaneo ◽  
Alan S Harris ◽  
Ulf Strömberg ◽  
Pier Mannuccio Mannucci
Keyword(s):  
Cardiac Surgery ◽  
Blood Loss ◽  
Meta Analysis ◽  
Postoperative Blood Loss ◽  
Controlled Trials ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Transfusion Requirements ◽  
The Mean ◽  
Excessive Blood Loss

SummaryThe effect of desmopressin (DDAVP) on reducing postoperative blood loss after cardiac surgery has been studied in several randomized clinical trials, with conflicting outcomes. Since most trials had insufficient statistical power to detect true differences in blood loss, we performed a meta-analysis of data from relevant studies. Seventeen randomized, double-blind, placebo-controlled trials were analyzed, which included 1171 patients undergoing cardiac surgery for various indications; 579 of them were treated with desmopressin and 592 with placebo. Efficacy parameters were blood loss volumes and transfusion requirements. Desmopressin significantly reduced postoperative blood loss by 9%, but had no statistically significant effect on transfusion requirements. A subanalysis revealed that desmopressin had no protective effects in trials in which the mean blood loss in placebo-treated patients fell in the lower and middle thirds of distribution of blood losses (687-1108 ml/24 h). In contrast, in trials in which the mean blood loss in placebo-treated patients fell in the upper third of distribution (>1109 ml/24 h), desmopressin significantly decreased postoperative blood loss by 34%. Insufficient data were available to perform a sub-analysis on transfusion requirements. Therefore, desmopressin significantly reduces blood loss only in cardiac operations which induce excessive blood loss. Further studies are called to validate the results of this meta-analysis and to identify predictors of excessive blood loss after cardiac surgery.

scholarly journals High-dose Aprotinin in Cardiac Surgery—A Prospective, Randomized Study

1994 ◽  
Vol 22 (5) ◽  
pp. 529-533 ◽  
Author(s):  
M. J. Swart ◽  
P. C. Gordon ◽  
P. B. Hayse-Gregson ◽  
R. A. Dyer ◽  
A. L. Swanepoel ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Placebo Group ◽  
Blood Loss ◽  
Artery Bypass ◽  
Randomized Study ◽  
Postoperative Blood Loss ◽  
High Dose ◽  
Maintenance Infusion ◽  
Transfusion Requirements ◽  
High Dose Aprotinin

Fifty patients undergoing primary coronary artery bypass surgery and 50 patients undergoing valve surgery received either high-dose aprotinin (2 million units loading dose, 2 million units added to the CPB prime, and 500,000 units/hr maintenance infusion) or placebo. Mean postoperative blood loss in the first six hours was reduced from 321 ml in the placebo group to 172 ml in the aprotinin group (95% confidence interval (CI) for difference = 95 to 189 ml). Seven patients in the placebo group and 16 patients in the aprotinin group did not require transfusion with homologous blood. This study adds to the growing body of evidence that the administration of high-dose aprotinin reduces blood loss and blood transfusion requirements associated with primary cardiac surgery.

Sign in / Sign up

Export Citation Format

Share Document