Recombinant factor VIIa for the treatment of bleeding in major
abdominal surgery including vascular and urological surgery - a review
and meta-analysis of published data.
Crit Care. 2008 Feb 15;12(1):R14
[Epub ahead of print] The meta-analysis of case series showed that in
a mean of 73% patients rFVIIa achieved at least a reduction of bleeding
and that the probability of survival is increased in patients responding
to rFVIIa. rFVIIa was not associated with an increased risk of
thromboembolism compared to placebo.
Coagulopathy in liver disease.
Recombinant factor VIIa as an adjunct in nonoperative management of
solid organ injuries in children.
J Pediatr Surg. 2008 Jan;43(1):195-199.
Recombinant factor VIIa is a useful
adjunctive therapy in pediatric patients with evidence of ongoing
hemorrhage from blunt abdominal injury and may reduce the need for
invasive therapeutic procedures and transfusions.
Successful combined use of
tranexamic Acid and unfractionated heparin for
life-threatening bleeding associated with
intravascular coagulation in a patient with
chronic myelogenous leukemia in blast crisis.
Int
J Hematol.
2007 Dec;86(5):403-6.
This case report is the first to describe
successful treatment with TA combined with
heparin for life-threatening intestinal bleeding
due to acute DIC associated with hematologic
malignancy.
Tranexamic acid reduces blood transfusion in total knee arthroplasty
even when a blood conservation program is applied.
Transfusion. 2007 Dec 7;
[Epub ahead of print] Tranexamic acid reduces
blood losses and transfusion requirements even when a blood conservation
program was used and it questions the usefulness of the postoperative
reinfusion drainsUse of Recombinant Activated Factor VII in Primary Postpartum
Hemorrhage: The Northern European Registry 2000 2004.
Treatment of refractory bleeding after cardiac operations with
low-dose recombinant activated factor VII (NovoSeven((R))): a propensity
score analysis.
Eur J Cardiothorac Surg.
2007 Nov 7; [Epub ahead of print]
Low dose of rFVIIa significantly reduced the 24-h blood
loss: 1610ml [ 1285-1800ml] versus 3171ml [2725-3760ml] in the study and
control groups, respectively (p<0.001). Thus, hourly bleeding was 51.1ml
[34.7-65.4ml] in patients receiving rFVIIa and 196.2ml/h [142.1-202.9ml]
in controls (p<0.001). Furthermore, patients receiving rFVIIa showed a
lower length of stay in the intensive care unit (p<0.001) and shorter
mechanical ventilation time (p<0.001). In addition, the use of rFVIIa
was associated with reduction of transfusion requirements of red blood
cells, fresh frozen plasma and platelets (all, p<0.001). Finally,
treated patients showed improved hemostasis with rapid normalization of
coagulation variables (partial thromboplastin time, international
normalized ratio, platelet count, p<0.001). In contrast, activated
prothrombin time and fibrinogen did not differ between groups (p=ns).
Role of Zinc in Hemostasis: A Review.
Biol Trace Elem Res.
2007 Oct 30; [Epub ahead of print] It
has been shown that hyperzincemia predisposes to increased coagulability,
and hypozincemia to poor platelet aggregation and increased bleeding time.
The blood clotting disturbances can be regressed by appropriate zinc intake
management.
Recombinant Activated Factor VII: A Solution to Refractory Haemorrhage
in Vascular Surgery?
Eur J Vasc Endovasc Surg. 2007 Oct 24; [Epub ahead of print]
Transfusion data from 9 patients was pooled and
analysed. Significant differences were found
between pre- and post- rFVIIa for packed red cell transfusions (mean 29.2
vs. 8.2, p=0.015). Intra-arterial thrombosis was reported in 3 cases.
RFVIIa may reduce haemorrhage in selected vascular surgical patients.
Randomized controlled trials are justified to definitively investigate its
role within this setting.
Recombinant factor VIIa in patients with platelet function disorders
or thrombocytopenia.
Hamostaseologie. 2007;27(4):251-262.
Case reports and short treatment series document
the efficacy and safety of rFVIIa to achieve haemostasis in patients with
platelet function disorders and thrombocytopenias of various origin...In
approximately half of the patients with thrombocytopenias, a single bolus of
rFVIIa has been shown to be sufficient in managing otherwise untreatable
bleeding complications. In these patients, haemostasis was achieved even at
platelet counts <20 000/microl, although the efficacy of rFVIIa increases at
higher platelet concentrations.
Recombinant factor VIIa: safety and efficacy.
Curr Opin Hematol. 2007
Sep;14(5):504-509. Review
Use of recombinant activated factor VII in massive postpartum
haemorrhage.
Eur J Obstet Gynecol Reprod Biol. 2007 Oct 8; [Epub ahead of
print] The main cause of postpartum haemorrhage PPH
was uterine atony (82%). In 21 cases rFVIIa was explicitly given to prevent
a hysterectomy. This was successful in 16 cases (76%). Relevant reduction or
complete cessation of bleeding after rFVIIa was noted in 24/27 cases (89%).
There was a reduction in blood product requirements following rFVIIa
administration. The dose of rFVIIa was variable and ranged from 16 to
128mug/kg. There appears to be a role for the use of rFVIIa in PPH
unresponsive to conventional therapy. Recombinant FVIIa can be helpful and
avoid an emergency hysterectomy.
Recombinant Factor VIIa: A Useful Tool for Life-Threatening Colonic
Bleeding. Report of a Case.
Dis Colon Rectum. 2007
Oct 5; [Epub ahead of print] No abstract available.
Recombinant activated factor VII in spinal surgery: a multicenter,
randomized, double-blind, placebo-controlled, dose-escalation trial.
Spine. 2007 Oct 1;32(21):2285-93.
No safety concerns were indicated for the use of rFVIIa in
patients at all doses tested; rFVIIa reduced adjusted blood loss and
adjusted transfusions during spinal surgery.
Potential role of recombinant activated factor VII for the treatment
of severe bleeding associated with disseminated intravascular coagulation: a
systematic review.
Blood Coagul Fibrinolysis. 2007 Oct;18(7):589-93.
Although limited, the data available suggest that rFVIIa
could have a potential role in this clinical setting. Large randomized
trials are needed, however, to confirm the preliminary results and to assess
the safety and dosing regimens of this agent in refractory bleeding
associated with disseminated intravascular coagulation.
Tranexamic acid diminishes intraoperative blood loss and transfusion
in spinal fusions for duchenne muscular dystrophy scoliosis.
Spine. 2007 Sep 15;32(20):2278-83.
Tranexamic acid significantly
reduces both intraoperative blood loss and the need for homologous
transfusion of whole blood and packed red blood cells in DMD patients
undergoing posterior spinal fusion for scoliosis.
Aprotinin may decrease blood loss in complex adult spinal deformity
surgery, but it may also increase the risk of acute renal failure.
Spine. 2007 Sep 15;32(20):2265-71.
In long spinal arthrodesis for complex adult spinal deformity
surgery, aprotinin does reduce intraoperative blood loss, but may increase
the risk of acute renal failure, especially in women over the age of 60.
Use of recombinant activated factor VII for massive postpartum
hemorrhage.
Acta Obstet
Gynecol Scand. 2007 Aug 29;:1-7 [Epub ahead of print]
Activated recombinant factor VII can be a life-saving drug in
patients with massive postpartum hemorrhage.
Dosing factor VIIa (recombinant) in nonhemophiliac patients with
bleeding after cardiac surgery.
Am J Health Syst Pharm. 2007 Sep 1;64(17):1808-12.
No particular dose of factor VIIa (recombinant) is strongly
supported in the literature for off-label use, and thromboembolic events may
be dose dependent. Use of the smallest possible dose is warranted because of
the high cost of factor VIIa (recombinant) and the potential for
thromboembolic events. A single dose of 2.4 or 4.8 mg or 45 microg/kg should
be considered.
Recombinant activated factor VII for a warfarinised Jehovah's Witness
with an acute subdural haematoma.
J Clin Neurosci. 2007 Aug 14; [Epub ahead of print] Case
report.
Randomized Study of Aprotinin Effect on Transfusions and Blood Loss in
Primary THA.
Clin Orthop Relat
Res. 2007 Aug 30; [Epub ahead of print]
Aprotinin reduced transfusions by 46% (30 of 176 versus 56 of 177 patients). Aprotinin reduced the total number of any blood units and the number of
allogeneic blood units transfused relative to placebo (48 versus 109 units
and 30 versus 72 units, respectively). Serious complications were similar in
the two groups (placebo, 11%; aprotinin, 10%). Our data suggest full-dose
aprotinin is safe and effective in decreasing blood transfusion in total hip
arthroplasty.
Dosing factor VIIa (recombinant) in nonhemophiliac patients with
bleeding after cardiac surgery.
Am J Health Syst Pharm. 2007 Sep 1;64(17):1808-12.No
particular dose of factor VIIa (recombinant) is strongly supported in the
literature for off-label use, and thromboembolic events may be dose
dependent. Use of the smallest possible dose is warranted because of the
high cost of factor VIIa (recombinant) and the potential for thromboembolic
events. A single dose of 2.4 or 4.8 mg or 45 microg/kg should be considered.
Is recombinant activated factor VII useful for intractable bleeding
after cardiac surgery?
Interact
Cardiovasc Thorac Surg. 2006 Aug;5(4):493-8. Epub 2006 May 3.
For patients with intractable bleeding post cardiac
surgery refractory to conventional haemostatic interventions, Factor VIIa is
recommended and its complication rates are low.
Aprotinin and nafamostat mesilate in liver surgery: effect on blood
loss.
Dig Surg. 2007;24(4):282-7. Epub
2007 Jul 27. There is currently no scientific
support for the routine use of aprotinin or nafamostat mesilate in patients
undergoing partial hepatectomy, whereas the efficacy of aprotinin in liver
transplantation is well established
Hemostatic alterations in liver disease: a review on pathophysiology,
clinical consequences, and treatment.
Dig Surg. 2007;24(4):250-8. Epub
2007 Jul 27. Review
Administration of Recombinant Activated Factor VII (NovoSeven) in
Three Cases of Uncontrolled Bleeding Caused by Disseminated Intravascular
Coagulopathy.
Clin Appl Thromb Hemost. 2007 Jul;13(3):313-7.
This article presents 3 patients with severe sepsis and
fulminant disseminated intravascular coagulation. Excessive microvascular
bleeding persisted despite conventional therapy, and surgical intervention
and radiologic embolization did not control bleeding. After administration
of recombinant activated factor VII, bleeding ceased in all patients, and no
overt thromboembolic events occurred.
The role of recombinant factor VIIa in on-pump cardiac surgery:
Proceedings of the Canadian Consensus Conference.
Can J Anaesth. 2007 Jul;54(7):573-82. In
cardiac surgery, the risks and benefits of rFVIIa are unclear, but current
evidence suggests that its benefits may outweigh its risks for rescue
therapy in selected patients.
Successful treatment of severe gastrointestinal bleeding secondary to
Crohn disease with recombinant factor VIIa.
South Med J. 2007
Jun;100(6):601-4. Acute gastrointestinal
bleeding is an unusual complication in Crohn disease. In this case, the use
of recombinant activated factor VIIa controlled the massive gastrointestinal
bleeding secondary to Crohn disease and without clinically significant
adverse effect.
Recombinant factor seven therapy for postoperative bleeding in
neonatal and pediatric cardiac surgery.
Ann Thorac Surg. 2007
Jul;84(1):161-8. The rFVIIa therapy seems to be
an effective treatment for severe bleeding in postoperative pediatric
cardiac surgery patients in the absence of surgical bleeding.
Clinical experience with recombinant activated factor VII in a series
of 45 trauma patients.
J R Army Med Corps.
2007 Mar;153(1):32-9. Haemostatic efficacy was
achieved in 43/45 (95.6%) patients following rFVIIa administration, and
transfusion requirements (defined as median units of packed red blood cells
administered in the 24-hour period following rFVIIa administration) were
reduced from 10 to 3 units (P < 0.001).
Efficacy and safety of aprotinin use for reoperative valvular surgery.
Ann Thorac Surg. 2007
Jun;83(6):2060-5. The mortality and morbidity
in redo valve surgery with aprotinin administration was comparable with
primary valve surgery without aprotinin. Bleeding and transfusion
requirements were significantly lower in redo patients receiving aprotinin.
Evaluating the safety implications of aprotinin use: the Retrospective
Evaluation of Aprotinin in Cardio Thoracic Surgery (REACTS).
J Thorac
Cardiovasc Surg. 2007 Jun;133(6):1547-52.
Aprotinin was not associated with negative myocardial or
cerebrovascular risks but did increase the risk of renal dysfunction. It is
not known whether the renal dysfunction reflects renal damage or a transient
reduction in glomerular filtration pressure.
Meta-Analysis Comparing the Effectiveness and Adverse Outcomes of
Antifibrinolytic Agents in Cardiac Surgery.
Circulation. 2007 May 28; [Epub ahead
of print] All antifibrinolytic agents were
effective in reducing blood loss and transfusion. There were no significant
risks or benefits for mortality, stroke, myocardial infarction, or renal
failure. However, high-dose aprotinin was associated with a statistically
significant increased risk of renal dysfunction
Ts12 combating coagulopathy.
ANZ J Surg. 2007 May;77 Suppl
1:A95.Review
Impact of aspirin with or without clopidogrel on postoperative
bleeding and blood transfusion in coronary surgical patients treated
prophylactically with a low-dose of aprotinin.
Eur
Heart J.
2007 Apr 12; [Epub ahead of print] In patients undergoing
first-time CABG and treated prophylactically with aprotinin, aspirin
and clopidogrel may be continued until surgery without increasing
postoperative bleeding or transfusion requirements.
Coagulopathy: Its Pathophysiology and Treatment in the Injured Patient.
World J Surg. 2007 Mar 30;
[Epub ahead of print] Review
Cost reduction of perioperative coagulation management in cardiac
surgery: value of 'bedside' thrombelastography (ROTEM).
Eur
J Cardiothorac Surg.
2007 Mar 28; [Epub ahead of print] Cumulative costs for treatment of
perioperative coagulation disorders can be reduced by 'bedside' ROTEM
analysis to achieve a selective substitution management. Saved costs for
blood- and coagulation products clearly outweighed the expenses of ROTEM.
Adequate differential coagulation management can therefore be cost-effective.
Recombinant FVIIa decreases perioperative blood transfusion
requirement in burn patients undergoing excision and skin grafting-Results
of a single centre pilot study.
Burns. 2007 Mar 21; [Epub ahead of print]
rFVIIa significantly decreased the total number of units of
blood components transfused per patient and percentage full thickness burn
wound excised compared with placebo (0.9 versus 2.2, p=0.0013) including
significant fewer red blood cell units (0.5 versus 1.1, p=0.004). We further
observed a trend towards improved graft survival (p=0.1) and a reduction in
multiple organ failures (p=0.08) in the rFVIIa-treated group. There were no
adverse events, in particular thromboembolic events.
Management of massive operative blood loss.
Minerva Anestesiol. 2007 Mar 24;
[Epub ahead of print] The present article reviews
pathomechanisms of coagulopathy in massive bleeding, as well as routine
laboratory tests and viscoelastic point-of-care hemostasis monitoring as the
diagnostic basis for therapeutic interventions.
Is the Use of rFVIIa Safe and Effective in Bleeding Neonates?: A
Retrospective Series of 8 Cases.
J Pediatr Hematol Oncol.
2007 Mar;29(3):145-150.In this study, the hemostatic agent rFVIIa
was well-tolerated and behaved in a safe and efficacious manner in all
infants treated for life-threatening bleeding and coagulation disorders.
Future prospective controlled trials are needed to determine the
efficacy, safety, tolerability, and possibly the optimal dose and timing
of rFVIIa administration. [Life-threatening postpartum hemorrhage and recombinant activated
factor rFVIIa NovoSeven((R)) use.]
J Gynecol Obstet Biol Reprod (Paris).
2007 Feb;36(1):78-82. Epub 2007 Jan 10. French. Recombinant
activated factor VII is an interesting and promising haemostatic agent
in the management of life-threatening postpartum haemorrhage
unresponsive to conventional treatment. |