fondaparinux and Wounds-and-Injuries

Surgery for pelvic or acetabular fractures carries a high risk of deep-vein thrombosis (DVT). Reports indicate that fondaparinux is a more effective thromboprophylactic agent than low molecular weight heparin (LMWH) after major orthopaedic surgery. The safety and efficacy of fondaparinux was evaluated in a new protocol used for DVT prophylaxis. One hundred and twenty seven patients with pelvic or acetabular fractures received either fondaparinux or enoxaparin and were analysed in a historical non-concurrent study. Specific review points included clinical deep-vein thrombosis (DVT) or pulmonary embolism (PE) and evidence of adverse effects such as bleeding or allergic reactions. Two patients that received enoxaparin were found to have a DVT and one patient had a PE. There was no documented DVT or PE in patients that received fondaparinux. The mean number of units of blood transfused postoperatively was higher in the enoxaparin group; however, multivariate regression modelling demonstrated no significant difference between the groups. The most current large randomised controlled studies investigating the administration of fondaparinux following joint arthroplasty or hip fracture surgery, have demonstrated a slight increase or a similar number of bleeding events in patients treated with fondaparinux when compared to those treated with enoxaparin. The current report supports that fondaparinux, in patients with pelvic and acetabular fractures, can be equally effective as enoxaparin and not associated with adverse bleeding events.

Topics: Acetabulum; Adult; Anticoagulants; Enoxaparin; Female; Fondaparinux; Fractures, Bone; Humans; Male; Orthopedic Procedures; Pelvic Bones; Polysaccharides; Postoperative Hemorrhage; Pulmonary Embolism; Venous Thrombosis; Wounds and Injuries

In trauma patients, pulmonary embolism occurs in up to 4% of cases and carries a mortality of 20-50%. The incidence of deep vein thrombosis (DVT) varies from 5 to 63% depending on patients' risk factors, modality of prophylaxis, and methods of detection. For these reasons, trauma patients require adequate DVT prophylaxis.. Spinal fracture or cord injury patients are at particular risk. Increasing injury severity, head injury, older age, lower limb injuries, and obesity are other risk factors. The current standard of care for DVT prophylaxis is enoxaparin (a low molecular weight heparin) as long as anticoagulation is not contraindicated. Unfractionated heparin alone does not provide sufficient protection against DVT. Selective factor Xa inhibitors such as fondaparinux are showing promising results. Other strategies for pulmonary embolism prevention include: graduated compression stockings, sequential compression devices, continuous passive motion, and prophylactic inferior vena cava filter. There is lack of consensus regarding the optimal DVT prophylaxis in trauma patients and few level I recommendations exist.. Best practice in thromboprophylaxis for trauma patients will remain on the basis of recommendations until definitive risk-benefit ratios are determined to justify the use of various mechanical and pharmacological measures, in combination or alone.

Topics: Anticoagulants; Critical Illness; Enoxaparin; Factor Xa Inhibitors; Fondaparinux; Humans; Incidence; Polysaccharides; Pulmonary Embolism; Risk Factors; Time Factors; Venous Thrombosis; Wounds and Injuries

Topics: Anticoagulants; Arthroplasty, Replacement, Knee; Arthroscopy; Drug Administration Schedule; Fondaparinux; Hematoma, Epidural, Spinal; Hematoma, Subdural, Spinal; Heparin; Heparin, Low-Molecular-Weight; Hip Fractures; Humans; Polysaccharides; Postoperative Complications; Practice Guidelines as Topic; Premedication; Punctures; Soft Tissue Injuries; Thromboembolism; Venous Thrombosis; Wounds and Injuries

To compare the effects and side-effects of fondaparinux sodium and low molecular weight heparin in patients with hypercoagulability accompanied with traumatic infection.. Thirty-six patients with post-traumatic infections in our hospital intensive care center were diagnosed with hypercoagulability from February 2012 to February 2013. These patients were randomly divided into 2 groups. In group F (18 patients), the patients were treated with fondaparinux sodium, 2.5 mg, 1/d for 11 d. In group L (18 patients), the patients were treated with low molecular weight heparin, 4100 U, 1/12 h for 11 d. The incidence of deep vein thrombosis, bleeding events and multiple organ dysfunction syndrome (MODS) and mortality of two groups after anticoagulation therapy were analyzed. Fibrinogen, D-dimer level and activity of antithrombin III were measured by the coagulation analyzer.. The incidence of deep vein thrombosis, MODS incidence and mortality were not significantly different between the two groups. The rate of bleeding evens in group F was lower than group L (p < 0.05). Antithrombin III got an upward trend after anticoagulant therapy, in which it was higher in group F than in group L on the 5th d and 11th d (p<0.05). Fibrinogen levels were gradually increased, and there was no significant difference between two groups (p>0.05). D-dimer was significantly decreased after anticoagulant therapy for 5 d (p<0.01), and there were significant differences between two groups on the 5th d and 7th d (p<0.05). It showed no significant difference on the 11th d (p>0.05).. Fondaparinux sodium and low molecular weight heparin can effectively improve coagulopathy in patients with traumatic infection. Compared with low molecular weight heparin, fondaparinux sodium may reduce the risk of bleeding events in patients with hypercoagulability accompanied by traumatic infection.

Topics: Adult; Aged; Female; Fibrin Fibrinogen Degradation Products; Fondaparinux; Heparin, Low-Molecular-Weight; Humans; Infections; Male; Middle Aged; Multiple Organ Failure; Polysaccharides; Thrombophilia; Venous Thrombosis; Wounds and Injuries

Surgery for pelvic or acetabular fractures carries a high risk of deep-vein thrombosis (DVT). Reports indicate that fondaparinux is a more effective thromboprophylactic agent than low molecular weight heparin (LMWH) after major orthopaedic surgery. The safety and efficacy of fondaparinux was evaluated in a new protocol used for DVT prophylaxis. One hundred and twenty seven patients with pelvic or acetabular fractures received either fondaparinux or enoxaparin and were analysed in a historical non-concurrent study. Specific review points included clinical deep-vein thrombosis (DVT) or pulmonary embolism (PE) and evidence of adverse effects such as bleeding or allergic reactions. Two patients that received enoxaparin were found to have a DVT and one patient had a PE. There was no documented DVT or PE in patients that received fondaparinux. The mean number of units of blood transfused postoperatively was higher in the enoxaparin group; however, multivariate regression modelling demonstrated no significant difference between the groups. The most current large randomised controlled studies investigating the administration of fondaparinux following joint arthroplasty or hip fracture surgery, have demonstrated a slight increase or a similar number of bleeding events in patients treated with fondaparinux when compared to those treated with enoxaparin. The current report supports that fondaparinux, in patients with pelvic and acetabular fractures, can be equally effective as enoxaparin and not associated with adverse bleeding events.

Topics: Acetabulum; Adult; Anticoagulants; Enoxaparin; Female; Fondaparinux; Fractures, Bone; Humans; Male; Orthopedic Procedures; Pelvic Bones; Polysaccharides; Postoperative Hemorrhage; Pulmonary Embolism; Venous Thrombosis; Wounds and Injuries

Venous thromboembolic events (VTE) remain a major cause of morbidity and mortality after trauma. Fondaparinux, a synthetic, nonheparin drug, has shown promise in reducing VTE in orthopaedic patients, but has not previously been studied in trauma patients. The goal of this study was to determine the safety and efficacy of fondaparinux when incorporated into our VTE prevention protocol. We hypothesized that the occult deep vein thrombosis (DVT) rate in high-risk patients receiving fondaparinux would be <5%.. Consented patients were assigned to a treatment group stratified by their VTE risk factors: high-risk, fondaparinux 2.5 mg subcutaneously once daily; very high-risk, both fondaparinux and pneumatic compression. Patients who were not candidates for anticoagulation received pneumatic compression only. All patients underwent surveillance venous ultrasonography imaging of upper and lower extremities on enrollment and weekly thereafter. Serum samples were analyzed for peak and trough drug concentration levels.. Overall incidence of DVT among the 87 enrolled patients was 4.6%. DVT developed in only 1 of 80 patients who received fondaparinux (1.2%). One patient assigned to fondaparinux had a DVT on initial scan before receiving prophylaxis. DVT developed in two of six patients in pneumatic compression only (33%). There were no episodes of pulmonary embolism, thrombocytopenia, or bleeding attributable to fondaparinux. Serum levels indicated adequate absorption of the drug and an effective dosing regimen.. Fondaparinux appears to offer protection against VTE in high-risk trauma patients. Its once-daily dosing regimen can improve compliance and reduce cost and eliminate risk of heparin-induced thrombocytopenia.

Topics: Adult; Aged; Anticoagulants; Combined Modality Therapy; Drug Administration Schedule; Female; Fondaparinux; Humans; Injections, Subcutaneous; Injury Severity Score; Intermittent Pneumatic Compression Devices; Male; Middle Aged; Pilot Projects; Polysaccharides; Pulmonary Embolism; Risk Assessment; Risk Factors; Treatment Outcome; Venous Thromboembolism; Wounds and Injuries

The safety and efficacy of nonvitamin K antagonist oral anticoagulants (NOACs) for the treatment of venous thromboembolism (VTE) have been established in randomized controlled trials, but limited data are available on their use in clinical practice across geographical regions.. In the international RE-COVERY DVT/PE observational study (enrollment January 2016 to May 2017), we sought to characterize the patient population and describe the prescribed anticoagulant. Patient characteristics and anticoagulants administered after objective diagnosis of VTE were recorded at the baseline visit and again at hospital discharge or at 14 days after the diagnosis, whichever was later.. A total of 6095 patients were included, 50.2% were male, and the mean age was 61.5 years. The most common comorbidities were hypertension (35%), diabetes mellitus (11%), cancer (11%), prior VTE(11%), and trauma/surgery (7%). Overall, 77% of patients received oral anticoagulants, with 54% on NOACs and 23% on vitamin K antagonists (VKAs); 20% received parenteral anticoagulation only. NOACs comprised about 60% of anticoagulant treatment in Europe and Asia but substantially less in Latin America (29%) and the Middle East (21%). For NOAC therapies, the distribution (as a percentage of the total cohort) was rivaroxaban 25.6%, dabigatran 15.5%, apixaban 11.3%, and edoxaban 1.7%. Treatment with NOACs was less frequent in patients who had cancer, chronic renal disease, heart failure, or stroke.. These findings enhance our understanding of baseline characteristics and the initial management of patients with VTE in routine practice.

Topics: Administration, Oral; Adult; Age Distribution; Aged; Anticoagulants; Asia; Comorbidity; Cross-Sectional Studies; Dabigatran; Diabetes Mellitus; Europe; Factor Xa Inhibitors; Female; Fondaparinux; Heparin; Humans; Hypertension; Latin America; Male; Middle Aged; Middle East; Neoplasms; Postoperative Complications; Practice Patterns, Physicians'; Pulmonary Embolism; Pyrazoles; Pyridines; Pyridones; Rivaroxaban; Thiazoles; Venous Thromboembolism; Venous Thrombosis; Wounds and Injuries

To evaluate the mean duration of treatment course with fondaparinux 2.5 mg (ARIXTRA(®)) in the setting of ambulatory general medicine, with respect to its indication in thromboprophylaxis for medically ill patients and to describe the population treated.. Observational, prospective, national, multicenter, pharmaco-epidemiological study, performed in France, at the request of the Transparency Commission (a division of the French Health Regulatory Authority). The general practitioners had to include the first three adult patients, considered as patients at high risk of venous thromboembolic events and immobilized for acute medical illness, treated with initiation of thromboprophylaxis by fondaparinux 2.5 mg.. Two hundred and seventeen general practitioners included 840 patients. The mean age of patients was 63.6±18.1 years, and 63% of patients (n=520/831) were females. The real total administration duration of the treatment by fondaparinux 2.5 mg was known for 797 patients and was 15.8±12.4 days on average (range: 1-90 days, median: 10 days). In 40% of patients, the duration ranged from 6 to 14 days [duration consistent with the summary of product characteristics (SmPC)]. Among the 834 patients analyzed, 569 (68%) suffered from at least one acute illness and had at least one risk factor for venous thromboembolism (VTE). The indication did fully comply with the summary of product characteristics of fondaparinux 2.5 mg in 52% of the patients (n=434/834 patients).. The results of the ArchiMed study support that the thromboprophylaxis treatment with fondaparinux 2.5 mg in ambulatory general medicine, and the associated medical conditions were usually consistent with the SmPC or guidelines. However, a difference was found for the duration and the initial indication, in situations that may be regarded as presenting a risk by the prescriber.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Back Pain; Bed Rest; Creatinine; Factor Xa Inhibitors; Female; Fondaparinux; General Practice; Humans; Immobilization; Male; Middle Aged; Polysaccharides; Practice Guidelines as Topic; Risk Factors; Surveys and Questionnaires; Thrombophilia; Time Factors; Treatment Outcome; Venous Thromboembolism; Wounds and Injuries; Young Adult