1. Moderate Pulmonary Embolism Treated With Thrombolysis(from the MOPETT Trial)(Am J Cardiol 2012) Clinical trials registry number?

2. Guidelines for reporting RCTs Consolidated standards of reporting trials (CONSORT) statement Comprises a 25-item checklist and a flow diagram, along with somebrief descriptive text The checklist focuses on how the trial was designed, analysed, and interpreted the flow diagram displays the progress of all participants through the trial Considered an evolving document, the CONSORT Statement is subjectto periodic changes as new evidence emerges Current version is CONSORT 2010 Is endorsed by prominent general medical journals, many specialtymedical journals, and leading editorial organizations Currently over 50% of the core medical journals listed in the Abridged Index Medicuson PubMed Is part of a broader effort, to improve the reporting of different types ofhealth research, and indeed, to improve the quality of research used indecision-making in healthcare 3. BackgroundThrombolysis is an effective tool in the treatment of massive pulmonaryembolism (PE).The possibility of ensuing intracerebral haemorrhage has caused areluctance to use thrombolysis for symptomatic PE withouthaemodynamic instability.The researchers experience with percutaneous endovenousintervention for deep venous thrombosis has suggested an exquisitelyfavourable pulmonary response to low-dose thrombolysis.A lower dose of the thrombolytic drug might be effective in PE, with theadditional benefit of an improved safety profile.No data are available on peripheral IV administration of low-dosethrombolysis for moderate PE in the reduction of pulmonary arterypressures after 2 years. 4. Objectives The purpose of the MOPETT trial was toassess the effect of low dose tPA (50 mgfor patients weighing 50 kg; 0.5 mg/kg forpatients weighing < 50kg ) on thereduction of pulmonary artery pressure at28 months in moderate PE 5. Methods Single centre, open label, randomised, controlled trial 1 centre in the US? Enrolment occurred between May 2008 and March 2010 Enrolment target 120 (110 to satisfy required samplesize) Variable duration of follow up (28 5 months) 6. Methods All patients received either unfractionated heparin ORsubcutaneous enoxaparin with initial preference given tothe latter drug. Enoxaparin was given to 48 of 61 (79%) TG patients and 49 of 60 (81%) CG patients Administration of unfractionated heparin was determined by the presence of renal insufficiency or patient preference 7. Methods Treatment group (low dose tPA plus modifiedanticoagulation) received Enoxaparin 1mg/kg subcut twice daily with initial dose not to exceed 80mg OR unfractionated heparin 70 U/kg bolus not exceeding 6000U with subsequent dose adjustment to keep the activated partial thromboplastin time at 1.5 to 2 times the baseline value Although tPA was infused the maintenance dose of unfractionated heparin was kept at 10U/kg/hour not to exceed 1000U/hour 3 hrs after termination of thrombolysis heparin increased to 18U/kg/hour Control group (best practice anticoagulation alone?)received Enoxaparin at 1 mg/kg subcut twice daily OR unfractionated heparin 80 U/kg bolus followed by 18U/kg/hour with the same partial thromboplastin time target 8. Eligibility Inclusion criteria Adult Moderate PE Signs and symptoms of PE plus CT pulmonary angiographic involvement of >70% involvement of thrombus in 2 lobar or left or right main pulmonary arteries or by a high probability ventilation/perfusion scan showing ventilation perfusion mismatch in 2 lobes A minimum of 2 new signs and symptoms consisting of Chest pain Tachypnea (RR 22 breaths/min) Tachycardia (HR 90 beats/min) Dyspnea Cough Oxygen desaturation (pO2 10 days >8 hours since start of parenteral anticoagulation SBP