Recombinant Activated Factor VII Use in Critically III Patients: Clinical Outcomes and Thromboembolic Events

Brophy, Gretchen M.; Candeloro, Christina; Robles, Jaime R.; Brophy, Donald F.

doi:10.1345/aph.1r729

Cited by 9 publications

(2 citation statements)

References 40 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Table 5 shows the most common off-label uses of rFVIIa in our study. In this study, the most common off-label uses of rFVIIa were for cardiac surgery, ICH, and PPH, (33%, 18.8% and 11% respectively) which is comparable to that of other registries [18,19]. The majority of patients received a single dose (60%) and the mortality rate in this study is 58%, which is comparable to those seen in previous studies [12,[20][21][22].…”

Section: Discussionsupporting

confidence: 85%

Validation of a Scoring System for Prediction of Clinical Outcome in the Offlabel Use of Recombinant Factor VIIa

Adam¹

2015

J Hematol Thrombo Dis

View full text Add to dashboard Cite

Background and Objectives: Recombinant factor VIIa (rFVIIa) is approved for treatment of inhibitors in hemophilia but has also been used for numerous off-label indications. Type of study: This study aims to validate a modified Biss scoring system in patients who received recombinant factor rFVIIa in Jeddah, Saudi Arabia. Materials and Methods: We included 70 patients who received rFVIIa for off-label indications over 12 months. Characteristics of survivor and non-survivor groups were compared including demographics, laboratory and clinical data. Using a modified Biss prognostic scoring system, based on the original scoring system used by Biss and Hanley, patients were divided into low (<1), intermediate (1-2) and high (≥3) score groups. Results: The mean age of patients was 46.1(±18.6) years. The most common off-label indications for rFVIIa treatment were to control bleeding associated with cardiac surgery (33%) and management of intracranial hemorrhage (18.8%). Forty three patients (61.6%) were at low risk, 20(28.6%) were at intermediate risk, and 7 (10%) were at high risk. Survivors were younger than non-survivors and less likely to have coagulopathy, or renal impairment at the time of treatment. The total prognostic score correlated to survival outcome (P ≤ 0.042); 73.2%, 22%, 4.9% of survivors had a low, intermediate and high score, respectively. Conclusions: Our results suggest that a modified Biss score could help predict survival of patients receiving rFVIIa. Prospective studies are needed to further validate the utility of this scoring system.

show abstract

Section: Discussionsupporting

confidence: 85%

Validation of a Scoring System for Prediction of Clinical Outcome in the Offlabel Use of Recombinant Factor VIIa

Adam¹

2015

J Hematol Thrombo Dis

View full text Add to dashboard Cite

show abstract

“…There was no difference in mortality between responders and nonresponders (68% and 69%, respectively, P = 0.9063). In 2013, a retrospective study reported on 1,459 critically ill patients in the ICU, of which 6% had cirrhosis, treated with rFVIIa . Patients treated with rFVIIa had higher mortality compared to controls (36% versus 16%, P < 0.0001), although they were found also to be sicker overall.…”

Section: Commentmentioning

confidence: 99%

Activated recombinant factor VIIa should not be used in patients with refractory variceal bleeding: It is mostly ineffective, is expensive, and may rarely cause serious adverse events

Sozio

Chalasani

2014

Hepatology

View full text Add to dashboard Cite

Activated Recombinant Factor VIIa Does Not Improve Mortality in Variceal Bleeding. Bendtsen F, D’Amico G, Rusch E, de Franchis R, Anderson PK, Lebrec D, et al. Effect of recombinant Factor VIIa on outcome of acute variceal bleeding: An individual patient based meta-analysis of two controlled trials. J Hepatol 2014; 61: 252–259. (Reproduced with Permission) Background & Aims Two randomized controlled studies have evaluated the effect of recombinant Factor VIIa (rFVIIa) on variceal bleeding in cirrhosis without showing significant benefit. The aim of the present study was to perform a meta-analysis of the two trials on individual patient data with special focus on high risk patients. Methods The primary outcome measure was the effect of rFVIIa on a composite five day endpoint: failure to control bleeding, 5-day rebleeding or death. Analysis was based on intention to treat. High risk was defined as active bleeding on endoscopy while under vasoactive drug infusion and Child-Pugh score >8. Results 497 patients were eligible for the meta-analysis; 308 (62%) had active variceal bleeding at endoscopy (oozing or spurting) and 283 of these had a Child-Pugh score >8. Analysis on the composite endpoint in all patients with bleeding from oesophageal varices did not show any beneficial treatment effect. However, failure rate for the primary composite end-point was significantly lower in treated patients with active bleeding at endoscopy (17%) compared to placebo (26%, p = 0.049). This difference was highly significant in patients with Child-Pugh score >8 and active bleeding at endoscopy (rFVIIa 16%, placebo 27%; p = 0.023). No significant treatment effect was found at 42 days. Five thromboembolic events occurred in rFVIIa treated patients compared to none in placebo treated patients. Conclusions The current meta-analysis shows a beneficial effect of rFVIIa on the primary composite endpoint of control of acute bleeding, prevention of rebleeding day 1–5 and 5-day mortality in patients with advanced cirrhosis and active bleeding from oesophageal varices at endoscopy. A major drawback of the treatment is a potential increased risk of arterial thrombo-embolic events. This treatment might be considered in patients with lack of control of bleeding after standard treatment.

show abstract

Hemostatic Resuscitation

Andrew¹,

Gurney²,

Meledeo³

2019

Damage Control Resuscitation

View full text Add to dashboard Cite

Recombinant Activated Factor VII Use in Critically III Patients: Clinical Outcomes and Thromboembolic Events

Abstract: While we cannot show direct causality between rFVIIa and the poor clinical outcomes documented in ICU patients, they provide important insight for critical care clinicians.

Cited by 9 publications

References 40 publications

Validation of a Scoring System for Prediction of Clinical Outcome in the Offlabel Use of Recombinant Factor VIIa

Validation of a Scoring System for Prediction of Clinical Outcome in the Offlabel Use of Recombinant Factor VIIa

Activated recombinant factor VIIa should not be used in patients with refractory variceal bleeding: It is mostly ineffective, is expensive, and may rarely cause serious adverse events

Hemostatic Resuscitation

Contact Info

Product

Resources

About