Haemostatic efficacy and safety of bolus and continuous infusion of recombinant factor VIIa are comparable in haemophilia patients with inhibitors undergoing major surgery

2007 ◽  
Vol 98 (10) ◽  
pp. 726-732 ◽  
Author(s):  
Prasad Mathew ◽  
Leonard Valentino ◽  
Michael Sumner ◽  
Stephanie Seremetis ◽  
Keith Hoots ◽  
...  
Keyword(s):  
Continuous Infusion ◽  
Surgical Management ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Orthopedic Procedures ◽  
Major Surgery ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Serious Adverse Events

SummaryBolus infusion (BI) recombinant factor VIIa (rFVIIa) administration is safe and effective in the surgical management of haemophilia patients with inhibitors but has not been compared directly with continuous infusion (CI). We conducted an open-label, randomized, multicenter trial comparing the efficacy and safety of rFVIIa administered by BI or CI for the surgical management of haemophilia A or B patients with inhibitors to FVIII or FIX. Safety was compared with that of a control group of noninhibitor patients receiving FVIII or FIX concentrates for major surgery. All inhibitor subjects received an initial bolus dose of 90 μg/kg rFVIIa and were then randomly assigned to BI (n=12) or CI (n=12). The BI group received 90 μg/kg rFVIIa every two hours (h) during surgery through day 5, then every four hours for days 6–10. The CI group received 50 μg/kg/h rFVIIa through day 5, then 25 mg/kg/h for days 6–10. The control group (n=12) received FVIII or FIX per institutional protocols. Twenty-two major surgeries included orthopedic procedures on the knee (n=13), hip (n=3), and abdominal/pelvis procedures (n=4). One patient with an autoimmune FVIII inhibitor randomized to the BI arm was excluded from efficacy analysis. Haemostatic efficacy of rFVIIa in each group was comparable: effective in 8/11 and 9/12 subjects in the BI and CI arms, respectively, and ineffective in three subjects in each arm. Serious adverse events were related to continued or increased bleeding. In conclusion, haemostatic efficacy and safety of BI and CI of rFVIIa are comparable for the surgical management of haemophilia subjects with inhibitors.

An Open-Label, Randomized, Parallel, Multi-Center Trial Comparing the Safety and Efficacy of rFVIIa When Administered as I.V. Bolus or I.V. Continuous Infusion to Hemophilia Patients with Inhibitors during and after Surgery.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3975-3975 ◽  
Author(s):  
Rajiv K. Pruthi ◽  
Prasad Mathew ◽  
Leonard A. Valentino ◽  
Stephanie V. Seremetis
Keyword(s):  
Treatment Group ◽  
Adverse Events ◽  
Continuous Infusion ◽  
Hemophilia A ◽  
Multicenter Trial ◽  
Major Surgery ◽  
Control Group ◽  
Current Standard ◽  
Open Label ◽  
Serious Adverse Events

Background and Purpose: Bolus infusion (BI) of recombinant FVIIa (rFVIIa) is effective for the treatment of bleeding and surgical prophylaxis in congenital hemophilia A or B patients with FVIII or IX inhibitors. In principle, continuous infusion (CI) of rFVIIa could maintain the hemostatic effect at a steady state while avoiding the peaks and troughs of repetitive BI. The purpose of this study was to compare the efficacy and safety of rFVIIa CI with rFVIIa BI in major surgery in hemophilia patients with inhibitors. Methods: A 10-day, open-label, randomized, multicenter trial was conducted in hemophilia A or B patients (age > 5 yr) with inhibitors to FVIII or FIX who underwent elective major surgery. Patients received rFVIIa as an initial bolus dose of 90 μg/kg followed by intermittent i.v. bolus (90 μg/kg) or i.v. continuous (50 μg/kg/hr) infusion. BI was administered every 2 hours during surgery and through Day 5, then every 4 hours for Days 6 to 10. CI was administered at 50 μg/kg/hr through Day 5 and at 25 μg/kg/hr Days 6 to10. A third control group of 10 non-inhibitor hemophilia A or B patients who underwent similar surgery and were treated with FVIII or FIX (based on current standard of care and physician’s choice) was assessed to compare adverse event and coagulation profiles. Safety was assessed throughout the study periods. Efficacy was defined as having no treatment failures during the given time and was evaluated at 48 hours, 5 days, and 10 days postoperatively. Treatment was considered ineffective in patients who received more than 2 additional doses of rFVIIa beyond the protocol-defined doses during a 24 hour period. Patients who received alternative hemostatic therapy following the permitted two additional doses of rFVIIa were considered treatment failures. Results: Twenty-four patients (12 CI arm, 12 BI arm) underwent 9 major types of surgeries. Knee (n=11) and hip (n=3) replacements were the most common surgeries. Recombinant FVIIa efficacy in major surgeries was 92% (11 CI, 11 BI) at 48 hours; 83% (10 CI) and 92% (11 BI) at Day 5; 83% (10 CI) and 75% (9 BI) at Day 10. Sixty-six rescue doses (rFVIIa, 90 μg/kg) were administered in the CI group (54 in one patient), and 7 in 3 patients in the BI group. Adverse events occurred more frequently in the CI treatment group (239; 141 in one patient) compared to the BI group (89 AEs); 64 AEs occurred in the control group. Eight patients (3 CI, 4 BI, 1 control) experienced 10 serious adverse events (SAEs). SAEs occurred most frequently in the BI treatment group (3 CI, 6 BI, 1 control). The types of SAEs were equally distributed among the three groups. There were no serious thromboembolic events reported during the study. Conclusions: This summary of 24 major surgeries indicates that rFVIIa is effective as prophylactic therapy for major surgery in hemophilia A or B patients with inhibitors. The numbers of patients were too small to distinguish efficacy rates between the two groups. The safety profile for patients treated with rFVIIa (BI or CI) was similar to the profile for non-inhibitor patients treated with other factors. Presented on behalf of the NovoSeven in Surgery Study Investigators.

Continuous Infusion of Coagulation Factor Products

2002 ◽  
Vol 36 (5) ◽  
pp. 882-891 ◽  
Author(s):  
Joan M Stachnik ◽  
Michael P Gabay
Keyword(s):  
Factor Viii ◽  
Continuous Infusion ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Case Reports ◽  
Coagulation Factor ◽  
Data Sources ◽  
Pharmacokinetic Data ◽  
Open Label ◽  
Intermittent Bolus

OBJECTIVE: To review clinical information related to the use of continuous infusion factor products in patients with hemophilia. Specifically, case reports and open-label trials are summarized involving the use of factor VIII and recombinant factor VIIa for a variety of indications including surgical prophylaxis, acute bleeding, primary prevention, and management of inhibitors. In addition, issues surrounding the use of continuous infusion of factor products such as pharmacokinetic rationale, stability/sterility, and cost are reviewed. DATA SOURCES: Primary and review articles were identified through a MEDLINE search (1990–June 2001) and through secondary sources. STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were evaluated, and all information deemed relevant was included in this review. DATA SYNTHESIS: Data concerning the administration of factor products are primarily detailed in open-label trials and case reports. Comparisons between intermittent bolus injections and continuous infusion of factor products are limited and primarily compare continuous infusion regimens with historical controls. The rationale behind the continuous-infusion approach is linked to the pharmacokinetics of factor products administered via this route. Pharmacokinetic data reveal that, with continuous infusion of factor products, a reduction in clearance and a maintenance of factor serum concentrations are noted. CONCLUSIONS: Administration of factor products (factor VIII and recombinant factor VIIa) via continuous infusion has produced favorable hemostatic effects compared with intermittent bolus injections. The advantages of continuous infusion include maintenance of a constant factor concentration, thereby reducing risk of bleeding from excessively low trough concentrations, and a decrease in factor consumption related to a reduction in factor clearance with constant infusion. Manufacturers recommend using reconstituted factor products either immediately or within 1–3 hours after reconstitution; however, several studies have found the products to be stable and sterile for longer periods.

scholarly journals Tamibarotene Compared to All-Trans Retinoic Acid (ATRA) As Add-on to Arsenic Trioxide (ATO) in Subjects with Relapsed Acute Promyelocytic Leukemia (APL)

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 220-220 ◽  
Author(s):  
Jianxiang Wang ◽  
Yingchang Mi ◽  
Bin Jiang ◽  
Xiequn Chen ◽  
Chunyan Ji ◽  
...  
Keyword(s):  
Retinoic Acid ◽  
Combination Therapy ◽  
Phase Iii ◽  
Control Group ◽  
Study Group ◽  
Efficacy And Safety ◽  
Intergroup Difference ◽  
Open Label ◽  
Serious Adverse Events ◽  
Retinoic Acid Syndrome

Abstract Background Combination therapy with ATRA and ATO is a standard therapy for relapsed APL. Despite the high complete remission (CR) rate with ATRA-ATO combination therapy, patients administered this combination for relapsed disease may acquire tolerance to ATRA, which reduces the CR rate in relapsed APL patients. Tamibarotene is a novel synthetic retinoid created in Japan with a several-fold-higher differentiation-inducing effect than ATRA, as well as low affinity for cellular retinoic acid-binding protein and absence of binding affinity for RARγ, unlike ATRA. It has been used for treating patients relapsed after ATRA therapy since 2005 in Japan. We conducted a phase III, randomized, open-label, parallel-group, active-controlled, multicenter clinical trial to compare tamibarotene-ATO and ATRA-ATO combination therapies in relapsed APL patients. Methods A Phase III, randomized, open-label, parallel-group, active-controlled, multicenter, study of 56 days treatment duration will evaluate the efficacy and safety of 6mg/m2/day Tamibarotene versus 25mg/m2/day ATRA as add-on to 0.15mg/kg/day ATO in subjects with relapsed APL. 71 subjects were randomly assigned to 1 of 2 treatment groups: ATRA-ATO (control group) or tamibarotene-ATO (study group). Results The number of subjects for efficacy analysis constituting a full analysis set (FAS) of all subjects administered study drugs, including drop-outs, was 35 each in the control and study groups. The number of subjects in each per protocol set (PPS), excluding drop-outs, was 27 and 33 in the control and study groups, respectively. CR rate for the FAS was significantly higher in the study group (80.00% vs. 54.29%; P = 0.0220, Table 1). In contrast, CR rate for the PPS was 84.85% and 70.37% for the study and control groups, respectively. The intergroup difference was 14.48% with a 97.1% confidence interval of -9.06 to 38.01%, which fulfilled requirements for non-inferiority of Δ = 0.10. These results verified the non-inferiority of the study to the control group. Of the patients who attained CR, the number who showed complete molecular remission (CRm) was higher in the study group, suggesting that a higher quality of remission was possibly attained in the study group (Table 2). Serious adverse events occurred in 3 control group patients (intracerebral hemorrhage, 2 and retinoic acid syndrome, 1) and 1 patient in the study group (type I respiratory failure). There was no significant intergroup difference in the incidences of serious adverse events. The most commonly reported adverse reactions included hypertriglyceridemia, hypercholesterolemia, rash, and elevation of ALT and AST levels; there was no significant intergroup difference in the incidences of any of these adverse reactions. Other adverse reaction findings were similar between the groups. Therefore, the tolerability observed in the study group was considered to be similar to that in the control. The only adverse finding that showed an appreciable intergroup difference was leukocytosis, which occurred at a significantly lower frequency in the study group than in the control group. Therefore, the therapeutic regimen of the study group might reduce the risk of retinoic acid syndrome, an important adverse reaction in treatment of APL, when the association of leukocytosis with development of retinoic acid syndrome is considered. Conclusion This controlled clinical trial demonstrated the efficacy and safety of combination therapy with tamibarotene and ATO in patients with relapsed APL. Tamibarotene-ATO combination therapy was considered not inferior in efficacy and safety to the standard combination of ATRA and ATO, and may be a useful new combination regimen for treating relapsed APL. Disclosures No relevant conflicts of interest to declare.

scholarly journals A Randomized Open Label Parallel Group Clinical Study to Evaluate the Efficacy and Safety of Clevira in Fever of Viral Origin

2019 ◽  
Vol 4 (09) ◽  
Author(s):  
Ramesh Kannan S. ◽  
Sivraman V. ◽  
Vanitha R. Muralikumar ◽  
Sakthibalan M. ◽  
Jayashree S. ◽  
...  
Keyword(s):  
Clinical Signs ◽  
Signs And Symptoms ◽  
Treated Group ◽  
Control Group ◽  
Efficacy And Safety ◽  
Structural Protein ◽  
Open Label ◽  
Serious Adverse Events ◽  
Viral Origin ◽  
Parallel Group

Objective: To evaluate the efficacy and safety of Clevira, an ayurvedic formulation in fever of viral origin. Methods: This was a prospective, randomised, multicentre, open label, parallel group interventional clinical end point study. Patients attending general outpatient department, were screened for viral fever including Dengue by using the haematological, Biochemical and microbiological anti body assay for Dengue and NS1 (Non-structural protein) antigen testing. Forty eight patients who satisfied the selection criteria were enrolled in the study. Participants were randomized into 4 groups with 12 patients in each group. Patients were given standard treatment. In addition, Tab. Clevira of Apex laboratories Pvt. Ltd., was administered to test groups. Results: There is highly significant improvement (P<0.001) in the subjects Temperature, fever score, arthralgia score, Myalgia score, Headache and loss of appetite, suggesting a good Analgesic and anti pyretic activity of Clevira. There is a significant improvement in platelet count in the Clevira treated group (P<0.01) when compared to the control group, proving its efficacy in treating thrombocytopenia. The improvement (P<0.01) in the WBC count in the Clevira treated group depicts the anti viral property of Clevira. The overall quality of life was better in Clevira treated group compared to the control group. There were no serious adverse events reported. Conclusion: Clevira is safe and efficacious in reversing thrombocytopenia and thus normalizing the platelet counts and relieving the clinical signs and symptoms (fever, myalgia, arthralgia, headache) of Viral fever associated with thrombocytopenia and other cases of viral fever without thrombocytopenia. Clevira is having good anti-viral, antipyretic, analgesic and immunomodulatory property. Hence, Clevira should be used as an add on drug in patients with viral fever with or without thrombocytopenia for a rapid recovery without any adverse effects.

Efficacy and safety of beta-blockers and prolonged bronchodilators in patients with heart failure with coronary artery disease and moderate to severe COPD

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Evdokimov ◽  
E Yushchuk ◽  
A Evdokimova ◽  
S Ivanova ◽  
I Sadulaeva
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Condition ◽  
Blood Pressure Monitoring ◽  
Beta Blockers ◽  
Control Group ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Severe Copd

Abstract Purpose To compare clinical efficacy and safety of various treatment regimens with the inclusion of beta-blockers, RAAS antagonists (ACE inhibitors or ARBs), prolonged bronchodilators (LABA, LAMA) in heart failure patients with CAD and COPD. Methods 385 patients (292 men and 93 women), aged 66.3±4.1 years, with CHF classes II to III (NYHA) combined with moderate to severe COPD (GOLD) and with LVEF less than 45% were randomized into nine groups: enalapril + LAMA (control group), nebivolol + enalapril + LAMA, nebivolol + losartan + LAMA, nebivolol + losartan + LABA, nebivolol + losartan + LAMA/LABA, carvedilol + enalapril + LAMA, carvedilol + losartan + LAMA, carvedilol + losartan + LABA, carvedilol + losartan + LAMA/LABA. Patients of all groups received complex CHF treatment comprising diuretics, nitrates, cardiac glycosides (if necessary). Clinical examination, TTE, 6-minute walk test (6MWT), 24-hour electrocardiogram and blood pressure monitoring, respiratory function test were assessed at baseline and after 6 months of treatment. The quality of life was evaluated by MYHFQ, SGRQ and mMRC scale. Results After 6 months of therapy the improvement of clinical condition and quality of life were marked in all groups. At the end of observation period there was a significant improvement of patients clinical condition, quality of life, reduction of mean CHF FC and dyspnea severity, increase of exercise tolerance, slowing of progression of CHF and COPD, improvement of the parameters of intracardiac hemodynamics, structural and functional parameters of the left and right heart (a decrease in the size of the atria, LV volumes and internal dimension at end-diastole and end-systole, cardiac index, LVMMI, an increase of LVEF, a significant decrease in systemic vascular resistance and the pulmonary hypertension grade, significant improvement in systolic and diastolic function of the ventricles, regression of pathological remodeling of the heart, reduction of heart rate, duration and frequency of myocardial ischemia episodes (including its “silent” form). The best results were obtained in groups using a beta-blocker (nebivolol or carvedilol), a RAAS antagonist, and a combination of long-acting bronchodilators (indacaterol and tiotropium) – group 5 and 9. It is worth noting that beta-blockers, LABA and LAMA were well tolerated in all observation groups and serious adverse events were absent. Conclusions The appointment of 3-generation beta-blockers to patients with CHF on the background of CAD and COPD can significantly increase the effectiveness of treatment and does not cause a deterioration in spirometry in patients with such cardiopulmonary pathology. In our opinion, the most important point in the appointment of beta blockers to patients with moderate to severe COPD is low start dose and slow titration of the dose at the beginning of the therapy. It is advisable to include in the complex therapy of such patients a combination of LABA and LAMA as a basic bronchodilator support. Funding Acknowledgement Type of funding source: None

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial

Neurosurgery ◽  
2017 ◽  
Vol 83 (1) ◽  
pp. 146-153 ◽  
Author(s):  
Pierre-Yves Borius ◽  
Stéphanie Ranque Garnier ◽  
Karine Baumstarck ◽  
Frédéric Castinetti ◽  
Anne Donnet ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Relief ◽  
Cancer Pain ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Standards Of Care ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label

Abstract BACKGROUND Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. OBJECTIVE To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. METHODS The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. EXPECTED OUTCOMES We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. DISCUSSION The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life.

scholarly journals Efficacy and safety of recombinant factor VIIa preparation (NovoSeven) for patients with congenital factor VII deficiency

2006 ◽  
Vol 17 (6) ◽  
pp. 695-705 ◽  
Author(s):  
Hideji HANABUSA ◽  
Kazushige OYAMA ◽  
Satoshi WATANABE ◽  
Yuzuru SAKAKIBARA ◽  
Yuji HIRAMATSU ◽  
...  
Keyword(s):  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Factor Vii ◽  
Efficacy And Safety ◽  
Factor Vii Deficiency ◽  
Congenital Factor

scholarly journals Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria and prevalence of molecular markers associated with artemisinin and partner drug resistance in Uganda

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Chris Ebong ◽  
Asadu Sserwanga ◽  
Jane Frances Namuganga ◽  
James Kapisi ◽  
Arthur Mpimbaza ◽  
...  
Keyword(s):  
Molecular Markers ◽  
Falciparum Malaria ◽  
Uncomplicated Malaria ◽  
Plasmodium Falciparum Malaria ◽  
Uncomplicated Falciparum Malaria ◽  
Pharmacokinetic Studies ◽  
Efficacy And Safety ◽  
Open Label ◽  
Serious Adverse Events ◽  
Line Therapy

Abstract Background In Uganda, artemether-lumefantrine (AL) is first-line therapy and dihydroartemisinin-piperaquine (DP) second-line therapy for the treatment of uncomplicated malaria. This study evaluated the efficacy and safety of AL and DP in the management of uncomplicated falciparum malaria and measured the prevalence of molecular markers of resistance in three sentinel sites in Uganda from 2018 to 2019. Methods This was a randomized, open-label, phase IV clinical trial. Children aged 6 months to 10 years with uncomplicated falciparum malaria were randomly assigned to treatment with AL or DP and followed for 28 and 42 days, respectively. Genotyping was used to distinguish recrudescence from new infection, and a Bayesian algorithm was used to assign each treatment failure a posterior probability of recrudescence. For monitoring resistance, Pfk13 and Pfmdr1 genes were Sanger sequenced and plasmepsin-2 copy number was assessed by qPCR. Results There were no early treatment failures. The uncorrected 28-day cumulative efficacy of AL ranged from 41.2 to 71.2% and the PCR-corrected cumulative 28-day efficacy of AL ranged from 87.2 to 94.4%. The uncorrected 28-day cumulative efficacy of DP ranged from 95.8 to 97.9% and the PCR-corrected cumulative 28-day efficacy of DP ranged from 98.9 to 100%. The uncorrected 42-day efficacy of DP ranged from 73.5 to 87.4% and the PCR-corrected 42-day efficacy of DP ranged from 92.1 to 97.5%. There were no reported serious adverse events associated with any of the regimens. No resistance-associated mutations in the Pfk13 gene were found in the successfully sequenced samples. In the AL arm, the NFD haplotype (N86Y, Y184F, D1246Y) was the predominant Pfmdr1 haplotype, present in 78 of 127 (61%) and 76 of 110 (69%) of the day 0 and day of failure samples, respectively. All the day 0 samples in the DP arm had one copy of the plasmepsin-2 gene. Conclusions DP remains highly effective and safe for the treatment of uncomplicated malaria in Uganda. Recurrent infections with AL were common. In Busia and Arua, the 95% confidence interval for PCR-corrected AL efficacy fell below 90%. Further efficacy monitoring for AL, including pharmacokinetic studies, is recommended. Trial registration The trail was also registered with the ISRCTN registry with study Trial No. PACTR201811640750761

Continuous infusion of recombinant factor VIIa for surgery in patients with deficiency of factor VII

2005 ◽  
Vol 94 (12) ◽  
pp. 1177-1180 ◽  
Author(s):  
Geir E. Tjønnfjord ◽  
Richard Wallensten ◽  
Uri Martinowitz ◽  
Gili Kenet ◽  
Sam Schulman
Keyword(s):  
Continuous Infusion ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Single Case ◽  
Thromboembolic Complication ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
Activated Factor Vii ◽  
Different Types ◽  
Fvii Deficiency

SummaryThe administration of recombinant activated factor VII (rFVIIa) by continuous infusion has provided a safe and convenient alternative to bolus injections in haemophiliacs with inhibitors, but it has only been reported in a single case with congenital factorVII (FVII) deficiency. The results of 12 consecutive surgical procedures in 7 patients with congenital FVII deficiency are reported here. rFVIIa was always given in continuous infusion, aiming at plasma FVII activity of 0.5 IU/mL. Treatment was given for 2 to 7 days with a mean total dose of 7.8 mg rFVIIa. Blood loss was as expected from the different types of procedures and the only thromboembolic complication was a superficial thrombophlebitis at the infusion site. This mode of substitution was therefore safe, effective and well tolerated.

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