Dataset Information

Intrapleural fibrinolytic therapy (IPFT) in loculated pleural effusions--analysis of predictors for failure of therapy and bleeding: a cohort study.

ABSTRACT: To assess risk factors associated with failure and bleeding in intrapleural fibrinolytic therapy (IPFT) for pleural effusions. Retrospective case series. Two tertiary-care centres in North America. We identified 237 cases that received IPFT for the treatment of pleural effusions. Data for 227 patients were compiled including demographics, investigations, radiological findings pretherapy and post-therapy and outcomes. Fibrinolytic therapy in the form of tissue plasminogen activator (t-PA) or streptokinase. Success of therapy is defined as the presence of both clinical and radiological improvement leading to resolution. Failure was defined as persistence (ie, ineffective treatment) or complications requiring intervention from IPFT. Incidence of bleeding post-IPFT, identifying factors related to failure of therapy and bleeding. IPFT was used in 237 patients with pleural effusions; 163 with empyema/complicated parapneumonic effusions, 32 malignant effusions and 23 with haemothorax. Overall, resolution was achieved in 80% of our cases. Failure occurred in 46 (20%) cases. Multivariate analysis revealed that failure was associated with the presence of pleural thickening (>2 mm) on CT scan (p=0.0031, OR 3, 95% CI 1.46 to 6.57). Bleeding was not associated with any specific variable in our study (antiplatelet medications, p=0.08). Pleural thickening on a CT scan was found to be associated with failure of IPFT.

SUBMITTER: Abu-Daff S

PROVIDER: S-EPMC3586180 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Intrapleural fibrinolytic therapy (IPFT) in loculated pleural effusions--analysis of predictors for failure of therapy and bleeding: a cohort study.

Abu-Daff Saleh S Maziak Donna E DE Alshehab Derar D Threader Jennifer J Ivanovic Jelena J Deslaurier Valerie V Villeneuve Patrick-James PJ Gilbert Sebastian S Sundaresan Sudhir S Shamji Farid F Lougheed Colleen C Seely Jean M JM Seely Andrew J E AJ

BMJ open 20130131 2

<h4>Objectives</h4>To assess risk factors associated with failure and bleeding in intrapleural fibrinolytic therapy (IPFT) for pleural effusions.<h4>Design</h4>Retrospective case series.<h4>Setting</h4>Two tertiary-care centres in North America.<h4>Participants</h4>We identified 237 cases that received IPFT for the treatment of pleural effusions. Data for 227 patients were compiled including demographics, investigations, radiological findings pretherapy and post-therapy and outcomes.<h4>Interven ...[more]

PMID: 23377992

Similar Datasets

Project description:BackgroundCombination intrapleural fibrinolytic and enzyme therapy (IET) has been established as a therapeutic option in pleural infection. Despite demonstrated efficacy, studies specifically designed and adequately powered to address complications are sparse. The safety profile, the effects of concurrent therapeutic anticoagulation, and the nature and extent of nonbleeding complications remain poorly defined.Research questionWhat is the bleeding complication risk associated with IET use in pleural infection?Study design and methodsThis was a multicenter, retrospective observational study conducted in 24 centers across the United States and the United Kingdom. Protocolized data collection for 1,851 patients treated with at least one dose of combination IET for pleural infection between January 2012 and May 2019 was undertaken. The primary outcome was the overall incidence of pleural bleeding defined using pre hoc criteria.ResultsOverall, pleural bleeding occurred in 76 of 1,833 patients (4.1%; 95% CI, 3.0%-5.0%). Using a half-dose regimen (tissue plasminogen activator, 5 mg) did not change this risk significantly (6/172 [3.5%]; P = .68). Therapeutic anticoagulation alongside IET was associated with increased bleeding rates (19/197 [9.6%]) compared with temporarily withholding anticoagulation before administration of IET (3/118 [2.6%]; P = .017). As well as systemic anticoagulation, increasing RAPID score, elevated serum urea, and platelets of < 100 × 109/L were associated with a significant increase in bleeding risk. However, only RAPID score and use of systemic anticoagulation were independently predictive. Apart from pain, non-bleeding complications were rare.InterpretationIET use in pleural infection confers a low overall bleeding risk. Increased rates of pleural bleeding are associated with concurrent use of anticoagulation but can be mitigated by withholding anticoagulation before IET. Concomitant administration of IET and therapeutic anticoagulation should be avoided. Parameters related to higher IET-related bleeding have been identified that may lead to altered risk thresholds for treatment.

Project description:ImportanceThere is a paucity of high-quality prospective randomized clinical trials comparing intrapleural fibrinolytic therapy (IPFT) with surgical decortication in patients with complicated pleural infections.ObjectiveTo assess the feasibility, safety, and efficacy of an algorithm comparing tissue plasminogen activator plus deoxyribonuclease therapy with surgical decortication in patients with complicated pleural infections.Design, setting, and participantsThis parallel pilot randomized clinical trial was performed at a single urban community-based center from March 1, 2019, to December 31, 2021, with follow-up for 90 days. Seventy-four individuals were screened and 48 were excluded. Twenty-six patients 18 years or older with clinical pleural infection and positive findings of pleural fluid analysis were included. Of these, 20 patients underwent randomized selection (10 in each group), and 6 were observed.InterventionsIntrapleural tissue plasminogen activator plus deoxyribonuclease therapy vs surgical decortication.Main outcomes and measuresPrimary outcomes were the percentage of patients enrolled to study completion and multidisciplinary adherence. Secondary outcomes included the number of patients with and the reason for inadequate screening, screening to enrollment failures, time to accrual of 20 patients or the number accrued at 1 year, and clinical data.ResultsTwenty-six patients were enrolled, 10 were randomized to each group, and 6 were observed. There was 100% enrollment to study completion in each treatment group, no protocol deviations, 2 minor protocol amendments, and no screening to enrollment failures. It took 32 months to enroll 26 patients. The 20 randomized patients had a median age of 57 (IQR, 46-65) years, were predominantly men (15 [75%]), and had a median RAPID (Renal, Age, Purulence, Infection Source, and Dietary Factors) score of 2 (IQR, 1-3). Treatment failure occurred in 1 patient and 2 crossover treatments occurred, all of which were in the IPFT group. Intraprocedure and postprocedure complications were similar between the groups. There were no reoperations or in-hospital deaths. Median duration of chest tube use was comparable in the IPFT (5 [IQR, 4-8] days) and surgery (4 [IQR, 3-5] days) groups (P = .21). Median hospital stay tended to be longer in the IPFT (11 [IQR, 4-18] days) vs surgery (5 [IQR, 4-6] days) groups, although the difference as not significantly different (P = .08). There were no 30-day readmissions or 30- or 90-day deaths.Conclusions and relevanceIn this pilot randomized clinical trial, the study algorithm was feasible, safe, and efficacious. This provides evidence to move forward with a multicenter randomized clinical trial.Trial registrationClinicalTrials.gov Identifier: NCT03873766.

Dataset Information

Intrapleural fibrinolytic therapy (IPFT) in loculated pleural effusions--analysis of predictors for failure of therapy and bleeding: a cohort study.

Publications

Intrapleural fibrinolytic therapy (IPFT) in loculated pleural effusions--analysis of predictors for failure of therapy and bleeding: a cohort study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets