Summary. Background: Hemodialysis (HD) grafts often fail because of stenosis at the venous anastomosis and thrombotic occlusion. Percutaneous management relies on thrombolysis with plasminogen activators, mechanical removal of thrombus, and angioplasty of the stenotic lesion. Objectives: This report describes a phase I trial using Plasmin (Human) TAL 05-00018, a direct-acting fibrinolytic agent, to evaluate safety and, secondarily, to establish effective thrombolytic dosing. Patients/Methods: Six cohorts of five patients with acute HD graft occlusion documented by angiography were treated with escalating dosages of plasmin (1,2,4,8,12, and 24 mg) infused over 30 min via criss-crossed pulse-spray catheters within the graft. The primary efficacy endpoint was ‡50% thrombolysis, as determined by comparison of pre-plasmin and 30-min post-plasmin fistulograms. Results: Of 31 subjects who received study drug (safety population), one withdrew and 30 completed the trial (evaluable for efficacy). There was no significant change in plasma a-2 antiplasmin or fibrinogen concentration, major bleeding did not occur, and there were no deaths. Serious adverse events in four patients were not related to the study drug. There was a dose-response relationship for the primary efficacy endpoint, all five subjects receiving 24 mg achieving >75% lysis. Conclusions: This first phase I study of Plasmin (Human) TAL 05-00018, infused into thrombosed HD grafts, documents safety at dosages of 1-24 mg and an effective thrombolytic dosage of 24 mg. The results establish a foundation for further clinical study of catheter-based plasmin administration in thrombotic disorders.

Study Design: Systematic literature review. Objectives: The impact of thromboembolic disease on the morbidity and mortality of patients with acute spinal cord injury is well documented, with rates as high as 67%-100% among untreated patients. The efficacy of mechanical prophylaxis as a stand-alone measure has been questioned, so we sought to determine a safe perioperative window for chemical anticoagulation use after spine surgery. Many surgeons have concerns anticoagulants may cause post-operative hematoma. Methods: A systematic literature review was performed, ultimately yielding 13 articles. Based on the existing literature and input from our multidisciplinary institutional trauma committee, a Spine Trauma DVT Prophylaxis Protocol was developed. Results: Effort was placed to identify cases within our institution in which patients suffered vertebral column fractures and/or spinal cord injuries. Of these 466 vertebral column fractures and/or spinal cord injuries, 4 patients were identified and diagnosed with DVTs while admitted. Conclusions: Of these patients, there is a clear dilemma with regard to safety of chemoprophylaxis use versus risk of developing a DVT. Though none of the patients developed a PE, utilizing the protocol would have led to earlier IVC filter placement or initiation of a VTE surveillance protocol in 2 of the patients. Initiation of enoxaparin before surgery in one patient (despite delay of surgical timing) may have avoided his subsequent LUE DVT. Though not appropriate for all clinical scenarios, we are confident that our treatment algorithm will prove beneficial for patient care in avoiding DVTs and helping trauma surgeons with evidence-based clinical decision making.

At all levels of American football, knee injuries are common, with injuries to the anterior cruciate ligament (ACL) making up a significant proportion. Historically, ACL injuries were career-altering for professional players, but innovative techniques in surgery and rehabilitation have returned many to the field. While there is a consensus on surgical techniques for ACL reconstruction, significant discrepancies remain on injury prevention and rehabilitation programs. This review article describes the burden of ACL injury on players in the National Football League, best practices in injury prevention and rehabilitation, and evidence-based recommendations for preparing injured athletes to return to play.

No abstract

No abstract

No abstract