Dataset Information

Efficacy and safety of 2-hour urokinase regime in acute pulmonary embolism: a randomized controlled trial.

ABSTRACT: Urokinase (UK) 2 200 U/kg.h for 12 hours infusion(UK-12 h)is an ACCP recommended regimen in treating acute pulmonary embolism (PE). It is unclear whether this dose and time can be reduced further. We compared the efficacy and safety of 20, 000 U/kg for 2 hours (UK-2 h) with the UK-12 h regime in selected PE patients.A randomized trial involving 129 patients was conducted. Patients with acute PE were randomly assigned to receive either UK-12 h (n = 70), or UK-2 h (n = 59). The efficacy was determined by the improvement of right heart dysfunction and perfusion defect at 24 h and 14 d post UK treatment. The bleeding incidence, death rate and PE recurrence were also evaluated.Similarly significant improvements in right heart dysfunction and lung perfusion defects were observed in both groups. Overall bleeding incidents were low in both groups. Major bleeding directly associated with UK infusion occurred in one patient in the UK-2 h group and one in the UK-12 h group. Mortality rates were low, with one reported fatal recurrent in the UK-12 h group and none in the UK-2 h group. When the rate of bleeding, death and PE recurrence were compared separately in the hemodynamic instability and the massive anatomic obstruction subgroups, no significant difference was found.The UK-2 h regimen exhibits similar efficacy and safety as the UK-12 h regimen for acute PE.

SUBMITTER: Wang C

PROVIDER: S-EPMC2806365 | biostudies-literature | 2009 Dec

REPOSITORIES: biostudies-literature

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Efficacy and safety of 2-hour urokinase regime in acute pulmonary embolism: a randomized controlled trial.

Wang Chen C Zhai Zhenguo Z Yang Yuanhua Y Yuan Yadong Y Cheng Zhaozhong Z Liang Lirong L Dai Huaping H Huang Kewu K Lu Weixuan W Zhang Zhonghe Z Cheng Xiansheng X Shen Ying H YH

Respiratory research 20091229

<h4>Backgrounds</h4>Urokinase (UK) 2 200 U/kg.h for 12 hours infusion(UK-12 h)is an ACCP recommended regimen in treating acute pulmonary embolism (PE). It is unclear whether this dose and time can be reduced further. We compared the efficacy and safety of 20, 000 U/kg for 2 hours (UK-2 h) with the UK-12 h regime in selected PE patients.<h4>Methods</h4>A randomized trial involving 129 patients was conducted. Patients with acute PE were randomly assigned to receive either UK-12 h (n = 70), or UK-2 ...[more]

PMID: 20040086

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Project description:BackgroundThere are different types of vena cava filter (VCF) available in clinical practice. However, limited data exist to determine whether one type is superior to another, and no single VCF is universally recommended in clinical guidelines. The objective of this study was to investigate the safety and efficacy of a novel VCF, Octoparms, for the prevention of pulmonary embolism (PE) and to compare it with the Celect filter.MethodsThis multicenter, randomized, open-label, parallel, positive-controlled, noninferiority trial was conducted in 10 centers across 6 provinces in China from October 2017 to March 2019. Patients who had confirmed lower extremity deep vein thrombosis or PE or who were at risk of PE with a clinical indication for VCF placement due to contraindication to or failure of anticoagulant therapy were included in the trial. The sample size for this trial was based on the assumption that the clinical success rate would be 95% and the noninferiority margin would be 10% for both filters. Each patient underwent baseline testing and was randomized using a web-based central system. Any additional interventions or standard treatments patients received along with the VCF placement were recorded. The primary endpoint was the overall clinical success rate, including technical and clinical success of filter placement and retrieval. The secondary endpoint was the safety of filter placement and retrieval, encompassing procedure-related and filter-related complications.ResultsA total of 188 patients were included and were divided into two groups: the Octoparms group (n=94) and the Celect group (n=94). Baseline characteristics and demographics were comparable between the two groups (P>0.05). Technical and clinical success rates for filter placement were achieved in 100% (188/188) of patients. The median dwelling time was 12.0 days (range, 4-190 days). Ten VCFs were left in situ as permanent devices. Of the remaining 178 patients, technical success and clinical success rates for filter retrieval were both achieved in 100% of cases (178/178). Clinical success rates were 92.6% (87/94) for the Octoparms group and 96.8% (91/94) for the Celect group, with a difference of -4.2% (hazard ratio 2.441, 95% confidence interval 0.612-9.741; P=0.206). The lower limit was greater than the noninferiority margin of -10%. Eight patients experienced a total of eight procedure-related complications. No filter-related complications, such as migration, deformation, inferior vena cava (IVC) penetration, peripheral organ damage, or IVC stenosis/occlusion, were observed (P>0.05).ConclusionsThe Octoparms filter exhibited a high rate of clinical success and a low rate of complications during placement and retrieval, demonstrating noninferiority to the Celect filter.

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Dataset Information

Efficacy and safety of 2-hour urokinase regime in acute pulmonary embolism: a randomized controlled trial.

Publications

Efficacy and safety of 2-hour urokinase regime in acute pulmonary embolism: a randomized controlled trial.

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