Antithrombin alfa in hereditary antithrombin deficient patients: A phase 3 study of prophylactic intravenous administration in high risk situations

2008 ◽  
Vol 99 (03) ◽  
pp. 616-622 ◽  
Author(s):  
R. Tait ◽  
Don Shaffer ◽  
Francesco Baudo ◽  
Bernard Boneu ◽  
Carl Dempfle ◽  
...  
Keyword(s):  
High Risk ◽  
Intravenous Administration ◽  
Elective Surgery ◽  
Vitamin K Antagonists ◽  
Standard Of Care ◽  
Vein Thrombosis ◽  
At Deficiency ◽  
Multi Center Study ◽  
Risk For Thrombosis ◽  
Deep Vein

SummaryDuring surgery and childbirth, patients with hereditary antithrombin (AT) deficiency are at high risk for thrombosis,and heparin prophylaxis may not be sufficiently efficacious. In these patients, exogenous AT may be used in association with heparin. A recombinant human AT (generic name: antithrombin alfa) has been developed. This multi-center study assessed the efficacy and safety of prophylactic intravenous administration of antithrombin alfa to hereditaryAT deficient patients in high risk situations, including elective surgery, childbirth, or cesarean section. Antithrombin alfa was administered prior to and during the high risk period for restoration and maintenance of AT activity at 100% of normal. Heparin, low-molecular-weight heparin, and/or vitamin K antagonists were used according to standard of care. The primary efficacy endpoint was the incidence of acute deep vein thrombosis (DVT) from baseline up to day 30 post dosing as assessed by independent central review of duplex ultrasonograms and/or venograms. Safety was assessed based on adverse events (AEs) and laboratory evaluations. Five surgical and nine obstetrical hereditary AT deficiency patients received antithrombin alfa for a mean period of seven days.No clinically overt DVT occurred. Central review of ultrasonograms identified signs of acute DVT in two out of 13 evaluable patients. No antithrombin alfa-related AEs were reported. No patient developed anti-antithrombin alfa antibodies. In conclusion, this study suggests that antithrombin alfa is a safe and effective alternative to human plasma-derived AT for treating hereditary AT deficiency patients at high risk for thromboembolic events.

Is Colour Doppler Ultrasound a Sensitive Screening Method in Diagnosing Deep Vein Thrombosis after Hip Surgery ?

1996 ◽  
Vol 75 (02) ◽  
pp. 242-245 ◽  
Author(s):  
Marie Magnusson ◽  
Bengt I Eriksson ◽  
Peter Kãlebo ◽  
Ramon Sivertsson
Keyword(s):  
Deep Vein Thrombosis ◽  
High Risk ◽  
Doppler Ultrasound ◽  
Predictive Value ◽  
Screening Method ◽  
Colour Doppler ◽  
Vein Thrombosis ◽  
Colour Doppler Ultrasound ◽  
Asymptomatic Patients ◽  
Deep Vein

SummaryPatients undergoing orthopedic surgery are at high risk of developing deep vein thrombosis. One hundred and thirty-eight consecutive patients undergoing total hip replacement or hip fracture surgery were included in this study. They were surveilled with colour Doppler ultrasound (CDU) and bilateral ascending contrast phlebography. The prevalence of proximal and distal DVT in this study was 5.8% and 20.3% respectively.CDU has a satisfactory sensitivity in patients with symptomatic deep vein thrombosis, especially in the proximal region. These results could not be confirmed in the present study of asymptomatic patients. The sensitivity was 62.5% (95% confidence interval: C.I. 24-91%) and the specificity 99.6% (C.I. 98-100%) for proximal DVT; 53.6% (C.I. 34-73%) and 98% (C.I. 96-99%) respectively for distal thrombi. The overall sensitivity was 58.1% (C.I. 39-75%) and the specificity 98% (C.I. 96-99%). The positive predictive value was 83.3% (C.I. 36-99%) and 75% (C.I. 51-91%) for proximal and distal DVT respectively. The negative predictive value was 98.9% (C.I. 98-100%) and 94.9% (C.I. 92-98%) for proximal and distal DVT respectively. The results of this study showed that even with a highly specialised and experienced investigator the sensitivity of CDU was too low to make it suitable for screening purposes in a high risk surgical population.

scholarly journals A preliminary study of intensivist-performed DVT ultrasound screening in trauma ICU patients (APSIT Study)

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Lloyd Roberts ◽  
Tom Rozen ◽  
Deirdre Murphy ◽  
Adam Lawler ◽  
Mark Fitzgerald ◽  
...  
Keyword(s):  
Intensive Care ◽  
Deep Vein Thrombosis ◽  
High Risk ◽  
Correlation Coefficient ◽  
Intraclass Correlation Coefficient ◽  
Major Trauma ◽  
Intraclass Correlation ◽  
Trauma Patients ◽  
Vein Thrombosis ◽  
Deep Vein

Abstract Background Multiple screening Duplex ultrasound scans (DUS) are performed in trauma patients at high risk of deep vein thrombosis (DVT) in the intensive care unit (ICU). Intensive care physician performed compression ultrasound (IP-CUS) has shown promise as a diagnostic test for DVT in a non-trauma setting. Whether IP-CUS can be used as a screening test in trauma patients is unknown. Our study aimed to assess the agreement between IP-CUS and vascular sonographer performed DUS for proximal lower extremity deep vein thrombosis (PLEDVT) screening in high-risk trauma patients in ICU. Methods A prospective observational study was conducted at the ICU of Alfred Hospital, a major trauma center in Melbourne, Australia, between Feb and Nov 2015. All adult major trauma patients admitted with high risk for DVT were eligible for inclusion. IP-CUS was performed immediately before or after DUS for PLEDVT screening. The paired studies were repeated twice weekly until the DVT diagnosis, death or ICU discharge. Written informed consent from the patient, or person responsible, or procedural authorisation, was obtained. The individuals performing the scans were blinded to the others’ results. The agreement analysis was performed using Cohen’s Kappa statistics and intraclass correlation coefficient for repeated binary measurements. Results During the study period, 117 patients had 193 pairs of scans, and 45 (39%) patients had more than one pair of scans. The median age (IQR) was 47 (28–68) years with 77% males, mean (SD) injury severity score 27.5 (9.53), and a median (IQR) ICU length of stay 7 (3.2–11.6) days. There were 16 cases (13.6%) of PLEDVT with an incidence rate of 2.6 (1.6–4.2) cases per 100 patient-days in ICU. The overall agreement was 96.7% (95% CI 94.15–99.33). The Cohen’s Kappa between the IP-CUS and DUS was 0.77 (95% CI 0.59–0.95), and the intraclass correlation coefficient for repeated binary measures was 0.75 (95% CI 0.67–0.81). Conclusions There is a substantial agreement between IP-CUS and DUS for PLEDVT screening in trauma patients in ICU with high risk for DVT. Large multicentre studies are needed to confirm this finding.

Deep Vein Thrombosis Prophylaxis: Audit of Practice in General Surgical Patients in a Teaching Hospital

2000 ◽  
Vol 15 (2) ◽  
pp. 71-74 ◽  
Author(s):  
O. Agu ◽  
A. Handa ◽  
G Hamilton ◽  
D. M. Baker
Keyword(s):  
Deep Vein Thrombosis ◽  
High Risk ◽  
Teaching Hospital ◽  
Surgical Patients ◽  
Thrombosis Prophylaxis ◽  
High Risk Patients ◽  
Vein Thrombosis ◽  
Dvt Prophylaxis ◽  
Risk Patients ◽  
Deep Vein

Objective: To audit the prescription and implementation of deep vein thrombosis (DVT) prophylaxis in general surgical patients in a teaching hospital. Methods: All inpatients on three general surgical wards were audited for adequacy of prescription and implementation prophylaxis (audit A). A repeat audit 3 months later (audit B) closed the loop. The groups were compared using the chi-square test. Results: In audit A 50 patients participated. Prophylaxis was correctly prescribed in 36 (72%) and implemented in 30 (60%) patients. Eighteen patients at moderate or high risk (45%) received inadequate prophylaxis. Emergency admission, pre-operative stay and inadequate risk assignment were associated with poor implementation of protocol. In audit B 51 patients participated. Prescription was appropriate in 45 (88%) and implementation in 40 (78%) patients (p< 0.05). Eleven patients at moderate or high risk received inadequate prophylaxis. Seven of 11 high-risk patients in audit A (64%) received adequate prophylaxis, in contrast to all high-risk patients in audit B. The decision not to administer prophylaxis was deemed appropriate in 5 of 15 (30%) in audit A compared with 6 of 10 (60%) in audit B. Conclusion: Increased awareness, adequate risk assessment, updating of protocols and consistent reminders to staff and patients may improve implementation of DVT prophylaxis.

scholarly journals Economic Analysis of Rivaroxaban for the Treatment and Long-Term Prevention of Venous Thromboembolism in Portugal

2014 ◽  
Vol 27 (5) ◽  
pp. 615 ◽  
Author(s):  
Isabel Fonseca Santos ◽  
Sónia Pereira ◽  
Euan McLeod ◽  
Anne-Laure Guillermin ◽  
Ismini Chatzitheofilou
Keyword(s):  
Pulmonary Embolism ◽  
Venous Thromboembolism ◽  
Standard Of Care ◽  
Quality Adjusted Life Years ◽  
Vein Thrombosis ◽  
Scenario Analyses ◽  
Life Years ◽  
Deep Vein ◽  
Quality Adjusted Life

<p><strong>Introduction:</strong> Venous thromboembolism is a burden on healthcare systems. The aim of this analysis was to project the long-term costs and outcomes for rivaroxaban compared to standard of care (enoxaparin/warfarin) in Portugal for the treatment and secondary prevention of venous thromboembolism.<br /><strong>Material and Methods:</strong> A Markov model was developed using event rates extracted from the EINSTEIN trials supplemented with literature-based estimates of longer-term outcomes. Core outcomes included per patient costs and quality-adjusted life years reported separately per treatment arm and incrementally, as well as cost per quality-adjusted life years gained. The deep vein thrombosis and pulmonary embolism indications were analysed separately. The analyses were conducted from the Portuguese societal perspective and over a 5-year time horizon. Costs and outcomes were discounted at a 5% annual rate. Several scenario analyses were undertaken to explore the impact on results of varying key modeling assumptions.<br /><strong>Results:</strong> Rivaroxaban treatment was associated with cost-savings for the treatment of deep vein thrombosis and was both cost-saving and more effective for the treatment of pulmonary embolism, compared with enoxaparin/warfarin.<br /><strong>Discussion:</strong> The results of the sensitivity and scenario analyses further supported that rivaroxaban is a cost-effective alternative to standard of care treatment. The use of an expert panel to derive some input values and the lack of Portuguese specific utilities were the main limitations.<br /><strong>Conclusion:</strong> Rivaroxaban represents an efficient alternative to using enoxaparin/warfarin in Portugal, as it’s associated with lower costs (for both indications) and greater quality adjusted life years (for the pulmonary embolism indication).</p><p><br /><strong>Keywords: </strong>Venous Thrombosis; Pulmonary Embolism; Rivaroxaban; Venous Thromboembolism.</p>

Should Patients with Deep Vein Thrombosis Alone be Treated as Those with Concomitant Asymptomatic Pulmonary Embolism? A Prospective Study

2002 ◽  
Vol 88 (12) ◽  
pp. 938-942 ◽  
Author(s):  
Harry Büller ◽  
Anthonie Lensing ◽  
Montserrat Bonet ◽  
Javier Roncales ◽  
Jordi Muchart ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Major Bleeding ◽  
Odds Ratio ◽  
Vitamin K Antagonists ◽  
Fixed Dose ◽  
Once Daily ◽  
Bleeding Rate ◽  
Vein Thrombosis ◽  
Deep Vein

SummaryThe established initial treatment of patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) consists of the administration of subcutaneous, weight adjusted, low-molecular weight heparin (LMWH). However, the use of the same LMWH dosages for patients with either DVT or PE is not supported by data from comparative studies.1,000 consecutive patients with acute, proximal DVT were prospectively evaluated. All patients underwent a ventilation-perfusion lung scan on admission, and remained in hospital for at least 7 days. Patients with silent PE received once daily 10,000 to 15,000 IU subcutaneous LMWH dalteparin according to body weight for 7 days, and then vitamin K antagonists. Patients with DVT alone received LMWH in a fixed dose of 10,000 IU once daily for at least 5 days, and then vitamin K antagonists. The rate of both, major bleeding and symptomatic PE episodes during the 7-day study period was evaluated.Thirteen patients (1.3%) developed recurrent PE (1 died) and 16 patients (1.6%) had major bleeding (7 died). Recurrent PE was significantly more common in patients with silent PE (9 of 258 patients, 3.5%) than in those with DVT alone (4 of 742 patients, 0.5%. Odds ratio: 6.5; p <0.001). There were no significant differences in bleeding rate between patients with silent PE and those with DVT alone. However, the use of a fixed 10,000 IU dose in patients with DVT alone led to a significantly lower bleeding rate in patients weighing over 70 kg: 1 of 349 patients (0.3%) as compared to 9 of 393 patients (2.3%) in those weighing less than 70 kg (odds ratio: 0.12; p = 0.018).Fixed-dose 10,000 IU of LMWH dalteparin once daily proved to be both effective and safe in patients with DVT alone. The observed recurrence rate of 0.5% in these patients compares favourably with the 3.5% rate in patients with silent PE. Furthermore, this fixed-dosage was also safe. Patients weighing over 70 kg had a significant decrease in the rate of major bleeding, and no compensatory increase in the rate of recurrent PE.

scholarly journals Inferior Vena Cava Agenesis and Deep Vein Thrombosis: A Pharmacological Alternative to Vitamin K Antagonists

2019 ◽  
Author(s):  
Inês Esteves Cruz ◽  
Pedro Ferreira ◽  
Raquel Silva ◽  
Francisco Silva ◽  
Isabel Madruga
Keyword(s):  
Deep Vein Thrombosis ◽  
Inferior Vena Cava ◽  
Vitamin K ◽  
Oral Anticoagulation ◽  
Inferior Vena ◽  
Vitamin K Antagonists ◽  
Anticoagulation Therapy ◽  
Vena Cava ◽  
Vein Thrombosis ◽  
Deep Vein

Inferior vena cava (IVC) agenesis is a rare congenital abnormality affecting the infrarenal segment, the suprarenal or the whole of the IVC. It has an estimated prevalence of up to 1% in the general population that can rise to 8.7% when abnormalities of the left renal vein are considered. Most IVC malformations are asymptomatic but may be associated with nonspecific symptoms or present as deep vein thrombosis (DVT). Up to 5% of young individuals under 30 years of age with unprovoked DVT are found to have this condition. Regarding the treatment of IVC agenesis-associated DVT, there are no standard guidelines. Treatment is directed towards preventing thrombosis or its recurrence. Low molecular weight heparin and oral anticoagulation medication, in particular vitamin K antagonists (VKAs) are the mainstay of therapy. Given the high risk of DVT recurrence in these patients, oral anticoagulation therapy is suggested to be pursued indefinitely. As far as we know, this is the first case reporting the use of a direct factor Xa inhibitor in IVC agenesis-associated DVT. Given VKA monitoring limitations, the use of a direct Xa inhibitor could be an alternative in young individuals with anatomical defects without thrombophilia, but further studies will be needed to confirm its efficacy and safety.

Prophylaxis Against Postoperative Thromboembolic Complications. A Comparison Between Dextran 70, Dihydroergotamin Heparin and a Sulphated Polysaccarid

1979 ◽  
Author(s):  
D. Bergqvist ◽  
T. Hallböök ◽  
B. Lindblad
Keyword(s):  
Elective Surgery ◽  
Hip Surgery ◽  
Perfusion Scintigraphy ◽  
X Ray ◽  
Vein Thrombosis ◽  
Dextran 70 ◽  
Postoperative Thrombosis ◽  
Fibrinogen Test ◽  
Deep Vein ◽  
Low Dose Heparin

Dextran 70, a fixed combination of dihydroergotamine and low dose heparin (DHEH) and a sulphated polysaccarid (PZ68B) have been compared for prevention of postoperative thromboembolism. The trial has been prospective with separate randomization of patients undergoing elective general surgery, elective hip surgery and hip frecture surgery. Deep vein thrombosis has teen diagnosed with the 125 I-fibrinogen test. In patients undergoing elective hip surgery pulmonary x-ray and perfusion scintigraphy have been made preoperatively and on postoperative day 7, The patients have been followed for 30 days to detect late fatal pulmonary emboli. 253 patients have been studied -(34 exclusions), the main results being as follows:In conclusion there is a good and equal prophylactic effect against postoperative thrombosis of DHEH and PZ68E in elective surgery, and the two methods are as effective as dextran 70 in hip fracture patients.

Diagnosis of Deep Vein Thrombosis in Asymptomatic High-Risk Patients

1995 ◽  
Vol 25 (1-2) ◽  
pp. 40-48
Author(s):  
Giancarlo Agnelli ◽  
Stefano Radicchia ◽  
Giuseppe G. Nenci
Keyword(s):  
Deep Vein Thrombosis ◽  
High Risk ◽  
High Risk Patients ◽  
Vein Thrombosis ◽  
Risk Patients ◽  
Deep Vein

scholarly journals Primary Thromboprophylaxis in Ambulatory Cancer Patients: Where Do We Stand?

Cancers ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 367 ◽  
Author(s):  
Frits I. Mulder ◽  
Floris T. M. Bosch ◽  
Nick van Es
Keyword(s):  
Risk Assessment ◽  
Clinical Practice ◽  
High Risk ◽  
Cancer Patients ◽  
Number Needed To Treat ◽  
Vascular Medicine ◽  
Assessment Scores ◽  
Vein Thrombosis ◽  
Risk Of Bleeding ◽  
Deep Vein

Venous thromboembolism (VTE), comprising deep-vein thrombosis and pulmonary embolism, is a frequent complication in ambulatory cancer patients. Despite the high risk, routine thromboprophylaxis is not recommended because of the high number needed to treat and the risk of bleeding. Two recent trials demonstrated that the number needed to treat can be reduced by selecting cancer patients at high risk for VTE with prediction scores, leading the latest guidelines to suggest such an approach in clinical practice. Yet, the interpretation of these trial results and the translation of the guideline recommendations to clinical practice may be less straightforward. In this clinically-oriented review, some of the controversies are addressed by focusing on the burden of VTE in cancer patients, discussing the performance of available risk assessment scores, and summarizing the findings of recent trials. This overview can help oncologists, hematologists, and vascular medicine specialists decide about thromboprophylaxis in ambulatory cancer patients.

Sign in / Sign up

Export Citation Format

Share Document