Recombinant activated factor VII for uncontrolled bleeding postcardiac surgery

Habib, Aly Makram; Mousa, Ahmed; Al‐Halees, Zohair

doi:10.1016/j.jsha.2016.03.001

Cited by 9 publications

(5 citation statements)

References 45 publications

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“…We found no significant differences noted between the two groups of this study with respect to DDAVP usage or dose; approximately half of the patients in each group received DDAVP. Recombinant activated factor VII has been used in the setting of acute hemorrhage as well as uncontrolled bleeding postcardiac surgery 22‐24 . The utilization of activated factor VII for the treatment of bleeding in patients without haemophilia was reviewed in a Cochrane Systematic Review and found a significant increase in the risk for thromboembolic embolic complications as well mixed evidence to support the use of activated factor VII as a general hemostatic agent 25 .…”

Section: Discussionmentioning

confidence: 99%

“…Recombinant activated factor VII has been used in the setting of acute hemorrhage as well as uncontrolled bleeding postcardiac surgery. [22][23][24] The utilization of activated factor VII for the treatment of bleeding in patients without haemophilia was reviewed in a Cochrane Systematic Review and found a significant increase in the risk for thromboembolic embolic complications as well mixed evidence to support the use of activated factor VII as a general hemostatic agent. 25 In our study, activated factor VII was only given to four patients, all in the no 4PCC group, before the US market release of 4PCC.…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of postoperative clinical outcomes in Jehovah's Witness patients who receive prothrombin complex concentrate during cardiac surgery

et al. 2020

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Background Patients who refuse allogeneic blood transfusions (alloBT) on the basis of religious doctrine, such as Jehovah's Witnesses (JWs), can pose a challenge when undergoing surgical procedures. During cardiac surgery, special considerations regarding surgical techniques and blood loss minimization strategies can lead to improved outcomes. Limited literature exists to guide the use of four‐factor prothrombin complex concentrate (4PCC) in this patient population undergoing cardiac surgery. Study Design and Methods This retrospective, single‐center study evaluated the impact of 4PCC on hemoglobin (Hgb) change from baseline to postoperative nadir within a 7‐day period among patients who refused alloBT during cardiac surgery. This study identified patients who refused alloBT from January 2011 to June 2017. Multivariable linear regression was used to control for confounding variables to evaluate the effectiveness of 4PCC. Results During the study timeframe, 79 patients met inclusion criteria, all of whom identified as JWs, and underwent cardiac surgery. Of these, 19 received intraoperative 4PCC. Multivariable linear regression found no difference in Hgb change in patients who received 4PCC vs those who did not. No significant differences were found in mortality, thromboembolic complications, or in‐hospital postoperative events. Conclusions In JWs undergoing cardiac surgery who refuse alloBT, intraoperative use of 4PCC was not associated with a difference in Hgb change within 7 days postoperatively when adjusting for confounding variables. In the event of excessive blood loss, the utilization of 4PCC may provide a viable option in JW patients who undergo cardiac surgery where few options exist to mitigate blood loss.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Evaluation of postoperative clinical outcomes in Jehovah's Witness patients who receive prothrombin complex concentrate during cardiac surgery

et al. 2020

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“…2 The use of concentrated coagulation factor replacement following CPB to control persistent bleeding after heparin reversal has become more commonplace. Studies of activated recombinant factor VII (rFVIIa) use [5][6][7][8][9][10][11] have found that rFVIIa is effective at reducing chest tube output and blood product transfusion requirements. [6][7][8][9] A recent study by Downey et al looked at rFVIIa in pediatric cardiac patients and found that perioperative administration of rFVIIa was associated with an increased incidence of postoperative thrombotic complications when compared with match controls.…”

Section: Introductionmentioning

confidence: 99%

“…Studies of activated recombinant factor VII (rFVIIa) use [5][6][7][8][9][10][11] have found that rFVIIa is effective at reducing chest tube output and blood product transfusion requirements. [6][7][8][9] A recent study by Downey et al looked at rFVIIa in pediatric cardiac patients and found that perioperative administration of rFVIIa was associated with an increased incidence of postoperative thrombotic complications when compared with match controls. 12 Studies evaluating prothrombin complex concentrate (PCC) found that use of PCC was associated with significantly decreased 24-h postoperative blood loss when compared with fresh frozen plasma [13][14][15] without increasing the risk of thromboembolic complications or mortality.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Prothrombin Complex Concentrate with Activated Factor VII Use for Bleeding Following Cardiopulmonary Bypass in Children

Benson

Hraška

Scott

et al. 2023

World J Pediatr Congenit Heart Surg

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Objective This study aims to compare the efficacy and safety of activated recombinant factor VII (rFVIIa) and prothrombin complex concentrate (PCC) in the treatment of bleeding complications following surgery requiring cardiopulmonary bypass (CPB) in children. Design/Methods This is a retrospective chart review of a single institution comprising patients aged 0 to 18 years old with congenital heart disease. Patients must have received either PCC or rFVIIa after coming off CPB. Our primary efficacy endpoint is time in the operating room from off-CPB to pediatric intensive care unit admission. Our primary safety endpoint is thrombosis through 30 days. Results Our primary efficacy outcome was significantly shorter in the PCC group compared with the rFVIIa group ( P < .0001). Similarly, secondary efficacy outcomes of packed red blood cell administration, chest tube output, and transfusion exposures all significantly favored PCC administration. However, CPB time was significantly longer, and body temperatures were significantly lower, in the rFVIIa group. Safety outcomes, including our primary safety outcome of thrombosis through 30 days, were similar between the two groups. Conclusion This study questions whether PCC could be favored over rFVIIa for hemostasis in children with congenital heart disease following CPB surgery. In addition, this study has found no difference when comparing PCC and rFVIIa in terms of safety outcomes, particularly thrombosis events. There are several limitations to this study due to the retrospective nature of the design and the differences between the two study groups. Despite the limitations, this study suggests that relatively early administration of PCC could be favored over delayed administration of rFVIIa to control recalcitrant post-CPB bleeding in the operating room.

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“…Recombinant activated factor VII (rFVIIa) was developed in the 1970s and used clinically in the 1980s for patients with haemophilia at doses of 90 mg/kg [1]. Off-label use of rFVIIa for perioperative cardiac surgical bleeding has been shown to reduce bleeding [2][3][4][5], blood product administration [4,6,7] and the rate of reoperations [2,8]. However, the use of rFVIIa for cardiac surgical bleeding has also been associated with increased mortality [9], thrombosis [10][11][12], stroke [8,12,13] and renal morbidity [9,10].…”

Section: Introductionmentioning

confidence: 99%

Very low-dose recombinant Factor VIIa administration for cardiac surgical bleeding reduces red blood cell transfusions and renal risk: a matched cohort study

Cotter¹,

Sharma

Campton

et al. 2021

Blood Coagulation &Amp; Fibrinolysis

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Outcomes following administration of very-low-dose recombinant activated factor VIIa (vld-rFVIIa) for cardiac surgical bleeding remain debatable. We sought to determine the association of vld-rFVIIa and adverse surgical outcomes. Retrospective, cohort matching of patients undergoing cardiac surgery who received vld-rFVIIa (median 13.02 μg/kg) for perioperative bleeding were matched to cardiac surgical patients who had bleeding and received standard of care for bleeding without Factor VIIa administration. Of the 362 matched patients (182 in each group), patients who received rFVIIa required significantly less red blood cell transfusions [median 3 units (range 0--60, IQR = 4 units) versus 4 units (range 2-34, IQR = 4 units); P = 0.0004], decreased length of hospital stay (median 8 versus 9 days; P = 0.0158) and decreased renal risk (P < 0.0001). Incidence of renal failure, postoperative infection, postoperative thrombosis, prolonged ventilation, total ICU hours and 30-day mortality were not different between the two groups. Vld-rFVIIa for cardiac surgical bleeding was associated with decreased red blood cell transfusion, renal risk and length of hospital stay without increased thromboembolism or mortality when compared to patients who had cardiac surgical bleeding and received standard of care without Factor VIIa.

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Recombinant activated factor VII for uncontrolled bleeding postcardiac surgery

Abstract: In this analysis, rFVIIa succefully reduced the chest tube bleeding and blood products transfused during severe post cardiac surgical bleeding. However, safety of rFVIIa remains unclear. Prospective controlled trials are still needed to confirm the role of rFVIIa.

Cited by 9 publications

References 45 publications

Evaluation of postoperative clinical outcomes in Jehovah's Witness patients who receive prothrombin complex concentrate during cardiac surgery

Evaluation of postoperative clinical outcomes in Jehovah's Witness patients who receive prothrombin complex concentrate during cardiac surgery

Comparison of Prothrombin Complex Concentrate with Activated Factor VII Use for Bleeding Following Cardiopulmonary Bypass in Children

Very low-dose recombinant Factor VIIa administration for cardiac surgical bleeding reduces red blood cell transfusions and renal risk: a matched cohort study

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