Successful use of activated recombinant factor VII to control bleeding abnormalities in a patient with a left ventricular assist device

Ziętkiewicz, Mirosław; Garlicki, M; Domagała, Jerzy; Wierzbicki, Karol; Drwiła, Rafał; Pfitzner, Roman; A, Dziatkowiak

doi:10.1067/mtc.2002.119328

Cited by 43 publications

(27 citation statements)

References 4 publications

(3 reference statements)

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“…The rationale for the study were the anecdotal reports of successful use of rFVIIa in cardiac surgery in adults with excessive bleeding [10][11][12][13][14][15].…”

Section: Discussionmentioning

confidence: 99%

Elective administration in infants of low-dose recombinant activated factor VII (rFVIIa) in cardiopulmonary bypass surgery for congenital heart disease does not shorten time to chest closure or reduce blood loss and need for transfusions: a randomized, double-blind, parallel group, placebo-controlled study of rFVIIa and standard haemostatic replacement therapy versus standard haemostatic replacement therapy

Ekert

Eyers²,

Cochrane³

et al. 2006

Blood Coagulation &Amp; Fibrinolysis

105

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We investigated the effectiveness of prophylactic administration of recombinant activated factor VII (rFVIIa) for cardiopulmonary bypass surgery in children under 1 year old with congenital heart disease (CHD) in a double-blinded, placebo-controlled study. The rFVIIa dose was 40 microg/kg and all patients also received standard haemostatic replacement therapy. The primary endpoint was the time to chest closure from neutralization of heparin with protamine sulphate as this could be most objectively and accurately measured during surgery. Secondary endpoints were volumes of transfused blood, platelet concentrates and fresh-frozen plasma. All adverse events were recorded. In the intention-to-treat analysis there were 76 patients (40 in rFVIIa group and 36 in placebo group). The demographics and severity of CHD were similar in both groups. No benefit of rFVIIa prophylaxis was found in the time to chest closure, which was significantly prolonged in the rFVIIa group (rFVIIa mean +/- SE, 98.8 +/- 27.27 versus 55.3 +/- 29.15, P = 0.0263). In the 41 patients available for a follow-up visit 6 weeks after discharge, the chest closure time was also prolonged in the rFVIIa group (P = 0.0515). There were no significant differences in the secondary endpoints. Adverse events were similar in both groups.

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“…The rationale for the study were the anecdotal reports of successful use of rFVIIa in cardiac surgery in adults with excessive bleeding [10][11][12][13][14][15].…”

Section: Discussionmentioning

confidence: 99%

Elective administration in infants of low-dose recombinant activated factor VII (rFVIIa) in cardiopulmonary bypass surgery for congenital heart disease does not shorten time to chest closure or reduce blood loss and need for transfusions: a randomized, double-blind, parallel group, placebo-controlled study of rFVIIa and standard haemostatic replacement therapy versus standard haemostatic replacement therapy

Ekert

Eyers²,

Cochrane³

et al. 2006

Blood Coagulation &Amp; Fibrinolysis

105

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“…The short history of the latter drug’s use in controlling perioperative haemorrhage has generated numerous reports on its beneficial effects [8,9,10]. Although rFVIIa cannot solve all bleeding problems related to surgery, we found it to be highly effective.…”

Section: Discussionmentioning

confidence: 82%

“…One could argue that this justified the application of a higher dose; however, surgical haemostasis was satisfactory, the initial bleeding was controlled and the recurring bleed was not as massive. Low dosage is sufficient to control the majority of surgical bleeds, which are not complicated by a severe fibrinolytic haemorrhagic diathesis [10,11,12,13]. However, the literature argues convincingly that in cases of severe bleeding, which requires prolonged treatment and involves major laboratory test disturbances, a higher dose should definitely be considered with a view to controlling the haemorrhage.…”

Section: Discussionmentioning

confidence: 99%

Recombinant Factor VII (Activated) for Haemorrhagic Complications of Severe Sepsis Treated with Recombinant Protein C (Activated)

Michalska-Krzanowska

Czuprynska²

2006

Acta Haematol

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We report on 2 cases of severe sepsis treated with drotrecogin-alpha (Xigris, Eli Lilly), where massive perioperative haemorrhage required administration of recombinant factor VIIa. The first patient developed severe sepsis after surgery (laparoscopic cholecystectomy, laparotomy due to peritonitis). After 18 h of treatment with Xigris, the patient developed massive, refractory gastrointestinal and abdominal bleeding. Effective haemostasis was achieved after 2 doses of NovoSeven (Novo Nordisk, Denmark). The patient died due to a cerebral bleed. The second patient developed septic shock in the course of pyelonephritis and right hydronephrosis. She was treated with Xigris and nephrectomy. Uncontrollable perioperative bleeding was effectively treated with 2 doses of NovoSeven. The patient survived.

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“…Anecdotal data based on a limited number of patients, mainly adults, have shown that rFVIIa successfully provides hemostasis in uncontrolled perioperative and postoperative bleeding in cardiac surgery (2)(3)(4)(5)(6)(7). The doses used in the literature varied considerably, from 20 to 120 g/kg.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, it has been successfully used to provide hemostasis in several other conditions associated with bleeding (1). Regarding the use of rFVIIa in cardiac surgery, limited data are available, mainly on adult patients (2)(3)(4)(5)(6)(7). We investigated the efficacy of rFVIIa in children undergoing cardiac surgery with cardiopulmonary bypass who had postoperative bleeding unresponsive to optimal transfusions of platelet and fresh frozen plasma.…”

mentioning

confidence: 99%