- Participant Characteristics Randomized Trial with Anticoagulant Warfarin Side Effects
- Participant Characteristics Randomized Trial with Warfarin Dosage Anticoagulants
- Participant Characteristics Randomized Trial with Anticoagulant Warfarin Monitoring
- Warfarin Side Effects
- Warfarin Dosage
- Warfarin Use Monitoring
- Anticoagulant Therapy
- Pulmonary Embolism Treatment
- Novel Anticoagulants
- Anticoagulant Study
- JAMA Studies
- Long-term Oral Anticoagulation Therapy
- Anticoagulant Therapy Outcomes
Participant Characteristics Anticoagulants Randomized Trial JAMA
This clinical investigation that was published in The Journal of the American Medical Association (JAMA) on June 18, 2014, was a collaboration of efforts from PubMed, the Cochrane Library, EMBASE, EBSCO, Web of Science, and CINAHL since its inception from April 10, 2014.
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The goal of the study was to perform a systematic review of the literature and determine prespecified inclusion criteria based on relevant studies, which are as follows: randomized controlled design in patients with Pulmonary Embolism (PE) evaluating thrombolytic therapy as an intervention; a comparator group that included any of the following agents: low-molecular-weight heparin (LMWH), vitamin K antagonist, fondaparinux, or unfractionated heparin; and reporting of mortality outcomes. Trials that were compared with different thrombolytic agents against one another or different doses of the same thrombolytic drug were not included.
Pulmonary embolism (PE) is an important cause of morbidity and mortality with more than 100,000 US cases annually and as many as 25% of patients presenting with sudden death. Pulmonary embolism is associated with increased mortality rates for up to 3 months after the index PE event. Multiple studies and meta-analyses have evaluated the role of thrombolytic therapy in PE with largely discordant results.
Several recent trials have evaluated the role of thrombolytics in PE for the patients without definitive results, particularly for the end-point of mortality. Thus, this clinical investigation performed a meta-analysis of all randomized trials of thrombolytic therapy in PE. It aimed to ascertain associations of thrombolytic therapy with bleeding risk and potential mortality benefits, with special attention paid to the subpopulation of patients presenting with intermediate-risk PE.
Eligible studies were randomized clinical trials comparing thrombolytic therapy vs anticoagulant therapy in pulmonary embolism patients. Sixteen trials comprising 2115 individuals were identified. Eight trials comprising 1775 patients specified inclusion of patients with intermediate-risk pulmonary embolism.
**Main Outcomes and Measures:**
The primary outcomes were all-cause mortality and major bleeding. Secondary outcomes were risk of recurrent embolism and intracranial hemorrhage (ICH). Peto odds ratio (OR) estimates and associated 95% CIs were calculated using a fixed-effects model.
The primary efficacy outcome was all-cause mortality and the primary safety outcome was major bleeding. Secondary efficacy and safety outcomes were risk of a recurrent PE and ICH, respectively. Definitions of major bleeding were according to definitions in the individual trials with ICH included as a major bleeding end-point in any trial that did not prespecify this.
The mortality and major bleeding outcomes were evaluated in the 8 studies that specified therapy for hemodynamically stable PE. In addition, a prespecified analysis was planned to evaluate the primary outcomes for trials published after 2009 (to evaluate the most updated randomized evidence). A priori, another planned exploratory analysis involved the outcomes in patients older than 65 years (trials where the mean age of participants in the thrombolytic group was >65 years), as worse outcomes with thrombolytics in elderly patients have been suggested by a recent large randomized trial of the issue.
About this Dataset
John Snow Labs; The Journal of the American Medical Association (JAMA);
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Warfarin Side Effects, Warfarin Dosage, Warfarin Use Monitoring, Anticoagulant Therapy, Pulmonary Embolism Treatment, Novel Anticoagulants, Anticoagulant Study, JAMA Studies, Long-term Oral Anticoagulation Therapy, Anticoagulant Therapy Outcomes
Participant Characteristics Randomized Trial with Anticoagulant Warfarin Side Effects, Participant Characteristics Randomized Trial with Warfarin Dosage Anticoagulants, Participant Characteristics Randomized Trial with Anticoagulant Warfarin Monitoring
|Source||Description of the primary outcomes taken from previous clinical trials published after 2009.||string||required : 1|
|Number_of_Patients||Description of the number of patients involved in the clinical trials reported.||integer||level : RAtiorequired : 1|
|Randomized_Treatment||Description of the thrombolytic drug used for the patients in the previous clinical trials.||string||required : 1|
|Dose_and_Coverage||Description of the dosage and coverage of the thrombolytic drug used for the patients in the previous clinical trials.||string||required : 1|
|Comparator||Description of the Anticoagulant drug used to compare the outcomes from the thrombolytic therapy.||string||required : 1|
|Major_Bleeding_Criteria||Description of the criteria for the bleeding outcomes based on the drug used.||string||required : 1|
|Follow_Up_Effect_Size||Description of the number of patients with major bleeding outcome.||string||-|
|Pulmonary_Embolism_Low||Description of the number of patients with low pulmonary embolism outcome.||string||-|
|Percentage_Pulmonary_Embolism_Low||Description of the percentage of patients with low pulmonary embolism outcome.||number||level : Ratio|
|Pulmonary_Embolism_Moderate||Description of the number of patients with moderate pulmonary embolism outcome.||string||-|
|Percentage_Pulmonary_Embolism_Moderate||Description of the percentage of patients with moderate pulmonary embolism outcome.||number||level : Ratio|
|Pulmonary_Embolism_High||Description of the number of patients with high pulmonary embolism outcome.||string||-|
|Percentage_Pulmonary_Embolism_High||Description of the percentage of patients with high pulmonary embolism outcome.||number||level : Ratio|
|Pulmonary_Embolism_Unclear||Description of the number of patients with pulmonary embolism with unclear outcomes.||integer||level : Ratio|
|Percentage_Pulmonary_Embolism_Unclear||Description of the percentage of patients with pulmonary embolism with unclear outcomes.||number||level : Ratio|
|Age||Description of the age range of patients included in the clinical trials.||string||required : 1|
|Mean_Range_or_Standard_Deviation||Description of either the mean or "center" of the data points; range or “difference” between the smallest value and largest values; and standard deviation or “value deviates” from the center or predicted average (y intercept).||string||required : 1|
|Notes||Description of the special note/notes regarding the age range of the participants in the clinical trial.||string||-|
|Number_of_Males||Description of the number of males included as participants in the clinical trials.||integer||level : Ratiorequired : 1|
|Percentage_of_Males||Description of the percentage of males included as participants in the clinical trials.||number||level : Ratiorequired : 1|
|Source||Number of Patients||Randomized Treatment||Dose and Coverage||Comparator||Major Bleeding Criteria||Follow Up Effect Size||Pulmonary Embolism Low||Percentage Pulmonary Embolism Low||Pulmonary Embolism Moderate||Percentage Pulmonary Embolism Moderate||Pulmonary Embolism High||Percentage Pulmonary Embolism High||Pulmonary Embolism Unclear||Percentage Pulmonary Embolism Unclear||Age||Mean Range or Standard Deviation||Notes||Number of Males||Percentage of Males|
|UPETSG, 1970||160||Urokinase||(2000 U/lb, then 2000 U/lb/h for 12 h)||Heparin||Hematocrit drop >10 points ?2 units PRBCs||14||Cannot exclude potential patients in this category||Cannot exclude potential patients in this category||14||8.8||146.0||91.3||45 (<50)||55 (>50)||Precise ages of patients not provided; 50.6% of patients were younger than 50 years and 49.4% of patients 50 years or older.||92||57.3|
|Tibbutt et at, 1974||30||Streptokinase||(600 000 U over 30 min through PA catheter followed by 100 000 U/h IV for 72 h)||Heparin||Not prespecified||3||Cannot exclude potential patients in this category||Cannot exclude potential patients in this category||7||23.3||23.0||76.7||48.73||(25-71)||15||50.0|
|Ly et al, 1978||25||Streptokinase||(250 000 IU loading dose, then 100 000 IU/h for 72 h)||Heparin||Not prespecified||10||Cannot exclude potential patients in this category||4||16.0||2||8.0||19.0||76.0||53.20||(23-70)||11||44.0|
|Marini et al, 1988||30||Urokinase||(800 000 IU 12 h/d for 3 d or 3 300 000 IU for 12 h)||Heparin||Not prespecified||7||Cannot exclude potential patients in this category||Cannot exclude potential patients in this category||Cannot exclude potential patients in this category||30.0||100.0||53.00||(23-72)||18||60.0|
|Levine et al, 1990||58||Alteplase||(0.6 mg/kg of ideal body weight)||Heparin||ICH, RP, transfusion of ?2 units PRBCs, Hemoglobin drop >2 g/dL||10||Cannot exclude potential patients in this category||Cannot exclude potential patients in this category||Cannot exclude potential patients in this category||58.0||100.0||61.50||(2.7)||29||54.5|
|PIOPED, 1990||13||Alteplase||(40-80 mg)||Heparin||Not prespecified||7||Cannot exclude potential patients in this category||Cannot exclude potential patients in this category||Cannot exclude potential patients in this category||13.0||100.0||58.46||(15.81)||9||55.6|
|Dalla -Volta et al, 1992||36||Alteplase||(100 mg)||Heparin||ICH, any transfusion||30||Cannot exclude potential patients in this category||Cannot exclude potential patients in this category||36.0||100.0||64.68||(12.5)||12||33.0|
|Goldhaber et al, 1993||101||Alteplase||(100 mg)||Heparin||ICH, need for surgery||55||49.5||56||50.4||58.54||(17)||44||44.0|
|Jerjes-Sanchez et al, 1995||8||Streptokinase||(1 500 000 IU)||Heparin||Not prespecified||1 to 3||8||100.0||51.00||(22.9)||5||63.0|
|Konstantinides et a1, 2002||256||Alteplase||(100 mg)||Heparin||ICH, fatal, Hemoglobin drop >4 g/dL||30||155||60.5||80||31.3||21.0||8.2||62.08||(10.47)||122||47.6|