European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
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Patients who undergo major spinal surgery often require multiple blood transfusions. The antifibrinolytics are medications that can reduce blood-transfusion requirements in cardiac surgery and total knee arthroplasty. The present role of synthetic antifibrinolytics, especially tranexamic acid, in reducing peri-operative blood-transfusion requirements in spine surgery is still unclear. ⋯ The goal of the present review is to discuss the pharmacology of tranexamic acid briefly. A brief synopsis of the studies using the synthetic antifibrinolytics for spine surgery is presented. Finally, the potential risks and the benefits of antifibrinolytics are discussed.
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Randomized Controlled Trial Clinical Trial
Comparison of a high-intensity and a low-intensity lumbar extensor training program as minimal intervention treatment in low back pain: a randomized trial.
In a randomized, observer-blinded trial, the effectiveness of 3-month high-intensity training (HIT) of the isolated lumbar extensors was compared to low-intensity training (LIT). Eighty-one workers with nonspecific low back pain longer than 12 weeks were randomly assigned to either of the two training programs. Training sessions were performed on a modified training device that isolated the lower back extensors. ⋯ The high-intensity training group showed a higher strength gain (24 to 48 Nm) but a smaller decline in kinesiophobia (2.5 and 3.4 points, respectively), compared to the low-intensity training group. It can be concluded that high-intensity training of the isolated back extensors was not superior to a non-progressive, low-intensity variant in restoring back function in nonspecific (chronic) low back pain. In further research, emphasis should be put on identifying subgroups of patients that will have the highest success rate with either of these training approaches.
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Patients and physicians continue to be motivated to find methods to reduce the use of allogeneic blood. Even though donor screening has increased the safety of donated blood products, autologous blood is the most desirable source of red cells during the perioperative period. The methods commonly used to obtain autologous blood during the perioperative period can be initiated prior to the operative procedure (autologous preoperative donation, acute normovolemic hemodilution) or during surgery (cell scavenging). ⋯ If operative blood loss is not excessive, the replacement of autologous blood may provide an acceptable red cell mass. In addition to surgical blood loss, some of the key factors in determining how effective acute normovolemic hemodilution will be in limiting allogeneic transfusion are: the patient's initial hematocrit and blood volume; the volume of autologous blood removed prior to the operation; the effectiveness of the hemodilution; and the timing of autologous blood replacement. In contrast to autologous pre-donation, autologous blood removed during acute normovolemic hemodilution is usually stored and re-infused in the operating room.
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The pharmacological methods used to achieve systemic hemostasis have generated much discussion due to concerns of serious adverse effects (e.g., thromboembolic complications) and costs of therapy in addition to efficacy considerations. There are a limited number of well-controlled trials involving pharmacological hemostasis for spine surgery. In the largest double-blinded randomized controlled trial to date involving spine surgery, there was a trend toward reduced homologous transfusion in patients receiving aprotinin, but the only statistically significant result ( p<0.001) was a reduction in autologous red cell donations. ⋯ Smaller studies involving antifibrinolytic agents other than aprotinin have demonstrated reductions in blood loss and transfusion requirements in patients undergoing spine surgery, although the results were not always statistically significant. A very large randomized trial would be required to address comparative medication- and transfusion-related adverse events; such a trial involving patients undergoing cardiac surgery is currently being performed. Additionally, cost-effectiveness analyses are needed to help define the role of these agents based on the data that is available.
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This article focuses on our current understanding of the role of activated coagulation factor VII (FVIIa) in coagulation, the current evidence regarding the efficacy and safety of recombinant FVIIa (rFVIIa), and thoughts regarding the use of rFVIIa in spine surgery. rFVIIa is approved in many countries (including the European Union and the USA) for patients with hemophilia and inhibitors (antibodies) to coagulation factors VIII or IX. High circulating concentrations of FVIIa, achieved by exogenous administration, initiate hemostasis by combining with tissue factor at the site of injury, producing thrombin, activating platelets and coagulation factors II, IX and X, thus providing for the full thrombin burst that is essential for hemostasis. This "bypass" therapy has led some clinicians to use rFVIIa "off-label" for disorders of hemostasis other than hemophilia. ⋯ Preliminary reports have indicated that rFVIIa does not increase the perioperative incidence of thromboembolic events. However, full reports from large clinical trials regarding the efficacy and safety of rFVIIa in settings other than hemophilia have yet to appear in peer-reviewed publications. Until adequate data demonstrating safety and efficacy are fully reported, it would seem appropriate to reserve the use of rFVIIa in spinal surgery to those instances where conventional therapy cannot provide adequate hemostasis, and "rescue" therapy is required.