Becattini 2010.
| Study characteristics | ||
| Methods |
Study design: multi‐centre, double‐blind, randomised, placebo‐controlled study Method of randomisation: not described Blinding: blind for assessment of efficacy of tenecteplase Duration: July 2006 to December 2006 Exclusions post‐randomisation: not clearly stated Losses to follow‐up: 7 participants |
|
| Participants |
Country: Italy Setting: 15 Italian centres No. of participants: 58: 28 in tenecteplase + heparin group, 30 in placebo + heparin group Age (mean ± SD): 72.1 ± 1.2 tenecteplase + heparin group, 64.5 ± 2.5 placebo + heparin group Sex: 13 men, 15 women in tenecteplase + heparin group; 10 men, 20 women in placebo + heparin group Inclusion criteria: aged between 18 and 85 years with objective diagnosis of PE and onset of symptoms no more than 10 days before randomisation, normal blood pressure (SBP ≥ 100 mmHg), and RVD at echocardiography performed within 24 hours from the diagnosis of PE. The diagnosis of PE was to be done by multi‐detector CT scan, pulmonary angiography, or lung scan Exclusion criteria: chronic pulmonary hypertension, severe COPD, hypertension (SBP > 180 mmHg, DBP > 110 mmHg, or both), clinically relevant bleeding within the last 6 months, a haemorrhagic diathesis, active peptic ulcer, arterial aneurysm, arterial/venous malformation, cancer at increased risk for bleeding, history of stroke, intracranial or spinal surgery. Major surgery, biopsy, or trauma in the 2 months preceding admission were additional criteria for exclusion. Patients were excluded if they had received therapeutic doses of heparin (unfractionated or low‐molecular‐weight heparin) for longer than 72 hours before randomisation, thrombolytic treatment within the previous 4 days, or glycoprotein IIb/IIIa antagonists within the preceding 7 days; if they were on oral anticoagulation or had prolonged cardiopulmonary resuscitation (> 10 minutes) in the last 2 weeks. Severe hepatic or renal failure and subacute bacterial endocarditis were additional criteria for exclusion. Women were excluded in case of pregnancy, lactation, or delivery in the 30 days before randomisation |
|
| Interventions | All participants received UFH and VKA Treatment group: Tenecteplase was given as an IV weight‐adjusted bolus at a dose ranging from 30 to 50 mg, with a 5‐mg step every 10 kg from < 60 to ≥ 90 kg. Maximum bolus dose allowed was of 5000 IU (4000 IU for participants with bodyweight < 67 kg) Control group: placebo instead of tenecteplase Length of follow‐up: follow‐up at 24 hours, 7 days after inclusion; at or before hospital discharge for the outcome echocardiography assessment; at 7 days or before discharge for the outcome clinical deterioration; at 30 days from randomisation for the outcome recurrence of PE and death; at 7 days from randomisation or before discharge for the outcome adverse events |
|
| Outcomes |
|
|
| Funding | This work has been supported by a grant in aid from Boehringer Ingelheim, Italy to the Clinical Research Unit of the University of Perugia | |
| Declaration of interests | The authors have disclosed no conflicts of interest | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding for assessment of efficacy of tenecteplase; no other detailed information provided |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding for assessment of efficacy of tenecteplase; no other detailed information provided |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | About 12% of participants lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | Reported all outcomes |
| Other bias | Unclear risk | Small sample size may be a source of other bias |