scholarly journals The efficiency and safety of recombinant factor VIIa for bleeding in patients without haemophilia: a meta-analysis of 12 randomized controlled trials

2019 ◽  
Author(s):  
Ying Zhang ◽  
Yuting Wang ◽  
Youfa Zhou ◽  
Jian Li ◽  
Haiyan Zhou
Keyword(s):  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Meta Analysis ◽  
Controlled Trials ◽  
High Dose ◽  
Cochrane Central Register ◽  
Red Cell ◽  
Recent Trial ◽  
Vein Thrombosis ◽  
Red Cell Transfusion

Abstract Background: Recombinant factor VIIa (rFVIIa) is widely used for off-label indications to control bleeding and reduce blood transfusion. However, the efficacy and safety of rFVIIa for bleeding in patients without haemophilia are uncertain and worthy of further study. This meta-analysis has been updated to incorporate recent trial data.Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), PUBMED, EMBASE and other medical databases up to 20 July 2019. The results of this work are synthetized and reported in accordance with the PRISMA statement.Results: Twelve trials met our inclusion criteria. High dose rFVIIa reduced the requirements of red cell transfusion (mean difference [MD], -232.34; 95% confidence interval [CI]; -448.33 to 234.89). rFVIIa did not significantly affect mortality (relative risk[RR], 1.00;95%CI, 0.82–1.21), total thromboembolic events (RR, 1.13; 95%CI, 0.94–1.36), myocardial infarction (RR, 1.37; 95%CI, 0.92–2.05), deep vein thrombosis (RR, 0.83; 95%CI, 0.52–1.33), ICU-stay (RR, 0.40; 95%CI, -1.28 to 2.07) and numbers of patients for red cell transfusion (RR, 0.94; 95%CI, 0.83-1.08). However, it may increase the incidence of arterial events (RR, 1.38; 95%CI, 1.08–1.77).Conclusion: High dose rFVIIa is effective to reduce the need of red cell transfusion for bleeding in patients without haemophilia. However, it may increase the risk of arterial events.

scholarly journals The efficiency and safety of recombinant factor VIIa for bleeding in patients without haemophilia: a meta-analysis of 12 randomized controlled trials

2020 ◽  
Author(s):  
Ying Zhang ◽  
Yuting Wang ◽  
Youfa Zhou ◽  
Jian Li ◽  
Haiyan Zhou
Keyword(s):  
Randomized Controlled Trials ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Vein Thrombosis ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Deep Vein

Abstract Background: Despite widely use of recombinant factor VIIa (rFVIIa) for bleeding in patients without haemophilia, its efficiency and safety remain unclear. Therefore, we carried out a meta-analysis on this topic. Methods: We searched Cochrane Library, Web of Science, PubMed and Embase, from January 2008 to July 2019 for randomized controlled trials on the topic. The results of this work are synthesized and reported in accordance with the PRISMA statement. Results: Twelve trials met our inclusion criteria. rFVIIa over 200ug/kg reduced red blood cell (RBC) transfusions within 24 h by 232.34ml (95% confidence interval [CI]; -410.31 to -54.37). rFVIIa did not significantly reduce 30-day mortality (relative risk [RR], 1.00; 95%CI, 0.82-1.21), total thromboembolic events (RR, 1.13; 95%CI, 0.94-1.36), myocardial infarction (RR, 1.37; 95%CI, 0.92-2.05), deep vein thrombosis (RR, 0.83; 95%CI, 0.52–1.33), ICU staying (RR, 0.40; 95%CI, -1.28 to 2.07) and number of patients transfused RBC (RR, 0.94; 95%CI, 0.83-1.08). However, rFVIIa may increase the incidence of arterial thrombotic events (RR, 1.38; 95%CI, 1.08–1.77). Conclusion: rFVIIa over 200ug/kg reduced RBC transfusions for bleeding in patients without haemophilia. However, it may increase the risk of arterial thrombotic events.

scholarly journals Effect of restrictive versus liberal red cell transfusion strategies on haemostasis: systematic review and meta-analysis

2017 ◽  
Vol 117 (05) ◽  
pp. 889-898 ◽  
Author(s):  
Katherine Colman ◽  
Babette Prick ◽  
Johannes Duvekot ◽  
Connor Sweeney ◽  
Ayodele Odutayo ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Red Cells ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Red Cell ◽  
Risk Of Bleeding ◽  
Red Cell Transfusion ◽  
Liberal Transfusion

SummaryRed cells play a key role in normal haemostasis in vitro but their importance clinically is less clear. The objective of this meta-analysis was to assess if correction of anaemia by transfusing red cells at a high haemoglobin threshold (liberal transfusion) is superior to transfusion at a lower haemoglobin threshold (restrictive transfusion) for reducing the risk of bleeding or thrombotic events. We searched for randomised controlled trials in any clinical setting that compared two red cell transfusion thresholds and investigated the risk of bleeding. We searched for studies published up to October 19, 2016 in The Cochrane Central Register of Controlled Trials, MEDLINE, PubMed, Embase, and the Transfusion Evidence Library and ISI Web of Science. Relative risks (RR) or Peto Odds Ratios (pOR) were pooled using a random-effect model. Nineteen randomised trials with 9852 participants were eligible for inclusion in this review. Overall there was no difference in the risk of any bleeding between transfusion strategies (RR 0.91, 95 % confidence interval [CI] 0.74 to 1.12). The risk of severe or life-threatening bleeding was lower with a restrictive strategy (RR 0.75, 95 % CI 0.57 to 0.99). There was no difference in the risk of thrombotic events (RR 0.83, 95 % CI 0.61 to 1.13). The risk of any bleeding was not reduced with liberal transfusion and there was no overall difference in the risk of thrombotic events. Data from the included trials do not support aiming for a high haemoglobin threshold to improve haemostasis. PROSPERO registration number CRD42016035519.Supplementary Material to this article is available online at www.thrombosis-online.com.

scholarly journals Effectiveness and safety of steady versus intermittent high dose vitamin D supplementation for the prevention of falls and fractures among adults: a protocol for systematic review and network meta-analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e027349
Author(s):  
Banaz Al-khalidi ◽  
Joycelyne Efua Ewusie ◽  
Jemila Hamid ◽  
Samantha Kimball
Keyword(s):  
Systematic Review ◽  
Vitamin D ◽  
Comparative Effectiveness ◽  
Meta Analysis ◽  
Institutional Care ◽  
Vitamin D Supplementation ◽  
Controlled Trials ◽  
High Dose ◽  
Cochrane Central Register ◽  
Dosing Schedule

IntroductionClinical trials and systematic reviews of trials involving vitamin D supplementation have mainly focused on defining the optimal amount of vitamin D dosage. However, the comparative effectiveness of different dosing schedules (ie, daily vs bolus dosing schedule) has been largely unexplored; and currently, there is no consensus regarding the optimal vitamin D dosing schedule. Our objective is to conduct a systematic review and network meta-analysis (NMA) to evaluate the comparative effectiveness and safety of steady (eg, daily, weekly) and intermittent high-dose (eg, monthly, yearly) vitamin D dosing schedules; and to determine the effectiveness of the various dosing schedules and combinations of treatments.Methods and analysisWe will conduct a systematic search and review of literature from major medical databases (MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov) involving studies that compare vitamin D supplementation alone or in combination with calcium. Only randomised controlled trials (RCTs) will be considered. We will, however, consider various settings (eg, community, institutional care) and study designs (eg, cluster RCTs, cross-over trials). Our primary outcomes include falls and fractures including hip-fracture and non-vertebral fractures. Secondary outcomes will include muscle strength, physical performance, gait and mobility limitation. A Bayesian NMA will be conducted, and the results will be presented in the form of treatment effect estimates and ranking probabilities, with corresponding CIs. Pairwise meta-analysis will also be conducted for studies reporting head-to-head comparisons. Subgroup analysis will be performed with respect to pre-determined subgroups; including vitamin D status as measured by serum 25-hydroxyvitamin D levels, age and follow-up time. Sensitivity analysis will also be performed with respect to risk of bias.Ethics and disseminationThis study is a systematic review and meta-analysis of published RCTs; therefore, no ethical approval is required. Results will be disseminated through open access peer-reviewed publications.Systematic review registrationPROSPERO CRD42018112662.

A Systematic Review and Meta-analysis Comparing Anticoagulation versus No Anticoagulation and Shorter versus Longer duration of Anticoagulation for Treatment of Isolated Distal Deep Vein Thrombosis

2017 ◽  
Vol 43 (08) ◽  
pp. 836-848 ◽  
Author(s):  
Anita Ariyarajah ◽  
Christopher Oldmeadow ◽  
Alix Hall ◽  
Anoop Enjeti ◽  
Ming Lim
Keyword(s):  
Deep Vein Thrombosis ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Vein Thrombosis ◽  
Symptomatic Pulmonary Embolism ◽  
Proximal Extension ◽  
Distal Deep Vein Thrombosis ◽  
Deep Vein

AbstractIsolated distal deep vein thrombosis (DVT) represents an important clinical problem but there is no consensus regarding its management. The aim of this review was to evaluate the safety, efficacy, and shorter versus longer duration of anticoagulation in patients with isolated distal DVT. A systematic search was conducted using MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systemic Reviews. Studies reporting rates of symptomatic pulmonary embolism (PE), recurrent DVT, proximal extension, and/or major bleeding were included. Fourteen studies (six randomized controlled trials, eight cohorts) involving 2,918 patients met the eligibility criteria (with a total of 13 meeting criteria for the meta-analysis). Compared with no anticoagulation, anticoagulation was associated with a significant reduction in proximal extension (odds ratio [OR]: 0.29; 95% confidence interval [CI]: 0.13–0.67; p < 0.004), recurrent DVT (OR: 0.16; 95% CI: 0.04–0.65; p = 0.01), and the composite end-point of proximal extension/PE (OR: 0.34; 95% CI: 0.16–0.72; p = 0.005); however, no significant differences in PE (OR: 0.47; 95% CI: 0.17–1.34; p = 0.16) or major bleeding (OR: 1.49; 95% CI: 0.33–6.86; p = 0.60) were observed. Anticoagulation for a longer duration (≥8 vs. ≤6 weeks) was associated with a significant reduction in proximal extension (OR: 0.23; 95% CI: 0.11–0.48; p < 0.001) but not for other outcomes.

Effect of recombinant Factor VIIa on outcome of acute variceal bleeding: An individual patient based meta-analysis of two controlled trials

2014 ◽  
Vol 61 (2) ◽  
pp. 252-259 ◽  
Author(s):  
Flemming Bendtsen ◽  
Gennaro D’Amico ◽  
Ea Rusch ◽  
Roberto de Franchis ◽  
Per Kragh Andersen ◽  
...  
Keyword(s):  
Variceal Bleeding ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Acute Variceal Bleeding

scholarly journals Convalescent plasma therapy for COVID-19 patients: a protocol of a prospective meta-analysis of randomized controlled trials

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lajos Szakó ◽  
Nelli Farkas ◽  
Szabolcs Kiss ◽  
Szilárd Váncsa ◽  
Noémi Zádori ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Randomized Controlled Trials ◽  
Organ Failure ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Plasma Therapy ◽  
Monthly Basis ◽  
Randomized Controlled

Abstract Background Coronavirus disease 2019 (COVID-19) is an infection with possible serious consequences. The plasma of recovered patients might serve as treatment, which we aim to assess in the form of a prospective meta-analysis focusing on mortality, multi-organ failure, duration of intensive care unit stay, and adverse events. Methods A systematic search was conducted to find relevant registered randomized controlled trials in five trial registries. A comprehensive search will be done continuously on a monthly basis in MEDLINE (via PubMed), Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science to find the results of previously registered randomized controlled trials. The selection will be done by two independent authors. Data extraction will be carried out by two other independent reviewers. Disagreements will be resolved by a third investigator. An update of the search of the registries and the first search of the databases will be done on the 21st of July. Data synthesis will be performed following the recommendations of the Cochrane Collaboration. In the case of dichotomous outcomes (mortality and organ failure), we will calculate pooled risk ratios with a 95% confidence interval (CI) from two-by-two tables (treatment Y/N, outcome Y/N). Data from models with multivariate adjustment (hazard ratios, odds ratio, risk ratio) will be preferred for the analysis. P less than 0.05 will be considered statistically significant. In the case of ICU stay, weighted mean difference with a 95% confidence interval will be calculated. Heterogeneity will be tested with I2, and χ2 tests. Meta-analysis will be performed if at least 3 studies report on the same outcome and population. Discussion Convalescent plasma therapy is a considerable alternative in COVID-19, which we aim to investigate in a prospective meta-analysis.

scholarly journals Comparative efficacy and safety of different regimens of ranibizumab for neovascular age-related macular degeneration: a network meta-analysis of randomised controlled trials

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e040906
Author(s):  
Xinyu Zhao ◽  
Lihui Meng ◽  
Youxin Chen
Keyword(s):  
Adverse Events ◽  
Macular Degeneration ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Age Related Macular Degeneration ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Age Related ◽  
Randomised Controlled

ObjectiveTo give a comprehensive efficacy and safety ranking of different therapeutic regimens of ranibizumab for neovascular age-related macular degeneration (nAMD).DesignA systematic review and network meta-analysis.MethodsThe PubMed, Embase, Cochrane Central Register of Controlled Trials, and other clinical trial registries were searched up to 1 October 2019 to identify related randomised controlled trials (RCT) of different regimens of ranibizumab for nAMD. The primary efficacy outcome was the changes of best-corrected visual acuity (BCVA) at 1 year, the primary safety outcome was the incidence of severe ocular adverse events. Secondary outcomes such as changes of central retinal thickness (CRT) were evaluated. We estimated the standardised mean difference (SMD), ORs, 95% CIs, the surface under the cumulative ranking curves and the mean ranks for each outcome using network meta-analyses with random effects by Stata 14.0.ResultsWe identified 26 RCTs involving 10 821 patients with nAMD randomly assigned to 21 different therapeutic regimens of ranibizumab or sham treatment. Ranibizumab 0.5 mg (treat and extend, T&E) is most effective in terms of changes of BCVA (letters, SMD=21.41, 95% CI 19.86 to 22.95) and three or more lines of BCVA improvement (OR=2.83, 95% CI 1.27 to 4.38). However, it could not significantly reduce retreatment times compared with monthly injection (SMD=−0.94, 95% CI −2.26 to 0.39). Ranibizumab 0.5 mg (3+pro re nata)+non-steroidal anti-inflammatory drugs (NSAIDs) is most effective in reducing CRT and port delivery system of ranibizumab (100 mg/mL) could reduce the number of retreatment most significantly. All regimes have no more risk of severe ocular complications (including vitreous haemorrhage, rhegmatogenous retinal detachment, endophthalmitis, retinal tear and retinal pigment epithelium tear) or cardiocerebral vascular complications.ConclusionsRanibizumab 0.5 mg (T&E) is most effective in improving the visual outcome. The administration of topical NSAIDs could achieve additional efficacy in CRT reduction and visual improvement. Both interventions had acceptable risks of adverse events.

Sulodexide versus Control and the Risk of Thrombotic and Hemorrhagic Events: Meta-Analysis of Randomized Trials

2020 ◽  
Vol 46 (08) ◽  
pp. 908-918
Author(s):  
Behnood Bikdeli ◽  
Saurav Chatterjee ◽  
Ajay J. Kirtane ◽  
Sahil A. Parikh ◽  
Giuseppe M. Andreozzi ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Cardiovascular Mortality ◽  
Dermatan Sulfate ◽  
Meta Analysis ◽  
Arterial Disease ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Bleeding Events ◽  
Random Effects Models ◽  
All Cause Mortality

AbstractThrombotic cardiovascular disease (myocardial infarction [MI], stroke, and venous thromboembolism [VTE]) remains a major cause of death and disability. Sulodexide is an oral glycosaminoglycan containing heparan sulfate and dermatan sulfate. We conducted a systematic review and meta-analysis to determine the cardiovascular efficacy, and safety of sulodexide versus control in randomized controlled trials (RCTs). We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials for RCTs reporting cardiovascular outcomes in patients receiving sulodexide versus control (placebo or no treatment). Outcomes included all-cause mortality, cardiovascular mortality, MI, stroke, deep vein thrombosis (DVT), pulmonary embolism, and bleeding. We used inverse variance random-effects models with odds ratio (OR) as the effect measure. After screening 360 records, 6 RCTs including 7,596 patients (median follow-up duration: 11.6 months) were included. Patients were enrolled for history of MI, VTE, peripheral arterial disease, or cardiovascular risk factors plus nephropathy. Use of sulodexide compared with control was associated with reduced odds of all-cause mortality (OR 0.67, 95% confidence interval [CI] 0.52–0.85, p = 0.001), cardiovascular mortality (OR 0.44, 95% CI 0.22–0.89, p = 0.02), and MI (OR 0.70, 95% CI 0.51–0.96, p = 0.03), and nonsignificantly reduced odds of stroke (OR 0.78, 95% CI 0.45–1.35, p = 0.38). Sulodexide was associated with significantly reduced odds of VTE (OR 0.44, 95% CI 0.24–0.81, p = 0.008), including DVT (OR 0.41, 95% CI 0.26–0.65, p < 0.001), but not pulmonary embolism (OR 0.92, 95% CI 0.40–2.15, p = 0.86). Bleeding events were not significantly different in the two groups (OR 1.14, 95% CI 0.47–2.74, p = 0.48). In six RCTs across a variety of clinical indications, use of sulodexide compared with placebo or no treatment was associated with reduced odds of all-cause mortality, cardiovascular mortality, MI, and DVT, without a significant increase in bleeding. Additional studies with this agent are warranted.

scholarly journals Comparison of irinotecan and oxaliplatin as the first-line therapies for metastatic colorectal cancer: a meta-analysis

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sadayuki Kawai ◽  
Nozomi Takeshima ◽  
Yu Hayasaka ◽  
Akifumi Notsu ◽  
Mutsumi Yamazaki ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Significant Heterogeneity ◽  
Cochrane Central Register ◽  
First Line ◽  
Anti Vegf ◽  
Significant Difference ◽  
High Incidence

Abstract Background Irinotecan (IRI) and oxaliplatin (Ox) are standard therapeutic agents of the first-line treatments for metastatic colorectal cancer (mCRC). Previous meta-analyses of randomized controlled trials (RCTs) showed that treatment with Ox-based compared with IRI-based regimens was associated with better overall survival (OS). However, these reports did not include trials of molecular targeting agents and did not take methods for the administration of concomitant drugs, such as bolus or continuous infusion of 5-fluorouracil, into account. A systematic literature review was performed to compare the efficacy and toxicity profiles between IRI- and Ox-based regimens as the first-line treatments for mCRC. Methods This meta-analysis used data from the Cochrane Central Register of Controlled Trials, PubMed, and SCOPUS. The primary endpoint was OS, and the secondary endpoints were progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs). Results Nineteen trials involving 4571 patients were included in the analysis. No statistically significant difference was observed between the two groups in terms of OS, PFS, and ORR. There was no significant heterogeneity. Regarding ≥ grade 3 AEs, IRI-based regimens were associated with a high incidence of leukopenia, febrile neutropenia, and diarrhea. Moreover, there was a high incidence of thrombocytopenia and peripheral sensory neuropathy in patients who received Ox-based regimens. In a subgroup analysis, IRI combined with bevacizumab was correlated with a better PFS (HR = 0.90, 95% CI = 0.82–0.98, P = 0.02), but not with OS (pooled HR = 0.91, 95% CI = 0.80–1.03, P = 0.15). Conclusion Although the safety profiles of IRI- and Ox-based regimens varied, their efficacy did not significantly differ. The combination of anti-VEGF antibody and IRI was associated with better PFS compared with anti-VEGF antibody and Ox. Both regimens could be used as the first-line treatments for mCRC with consideration of the patients’ condition or toxicity profiles.

scholarly journals Iris-Claw Intraocular Lens: Anterior Chamber or Retropupillary Implantation? A Systematic Review and Meta-Analysis

Medicina ◽  
2021 ◽  
Vol 57 (8) ◽  
pp. 785
Author(s):  
I-Chia Liang ◽  
Yun-Hsiang Chang ◽  
Adrián Hernández Hernández Martínez ◽  
Chi-Feng Hung
Keyword(s):  
Anterior Chamber ◽  
Intraocular Lens ◽  
Meta Analysis ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled ◽  
Cell Counts ◽  
Iop Elevation ◽  
Iris Claw

Background and Objectives: Iris-claw intraocular lens (ICIOL) could be implanted in the anterior chamber (AC) or retropupillary (RP) in eyes lacking capsular and/or zonular support. Several studies have focused on comparing the efficacy and complications of these two techniques and we designed this research to review the published literatures. Materials and Methods: Peer-reviewed studies were collected through network databases (PubMed, Scopus, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov) and analyzed. The primary outcome was the standardized mean differences (SMDs) of pre- and post-operative corrected distant visual acuity (CDVA). The secondary outcome was the SMDs of pre- and post-operative intraocular pressure (IOP), endothelial cell counts (ECC), and the odds ratios (ORs) of post-operative IOP elevation and cystoid macular edema (CME). Comprehensive Meta-Analysis software was utilized to conduct statistical analysis. Results: Six studies (one randomized controlled trial and five retrospective case series) were relevant and included a total of 516 eyes (255 and 261 eyes in the AC ICIOL and RP ICIOL groups, respectively). The quantitative analysis showed no significant differences in CDVA (SMD: 0.164, 95% confidence interval (CI): −0.171 to 0.500), ECC (SMD: −0.011, 95% CI: −0.195 to 0.173), and IOP elevation events (OR: 0.797, 95% CI: 0.459 to 1.383). Lesser IOP reduction (SMD: 0.257, 95%CI: 0.023 to 0.490) and a relative increase in the incidence of CME (OR:2.315, 95% CI: 0.950 to 5.637) were observed in the AC ICIOL group compared with RP ICIOL group. Conclusions: Our meta-analysis indicated that AC and RP ICIOL seem to have equivalent visual outcomes. RP ICIOL may perform slightly better with more IOP reduction and lesser CME. More randomized controlled trials, which have higher patient participation and more outcomes are needed to confirm our conclusions.

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