Meta AnalysisID 7684
平衡获益与风险：肝素在主动脉内球囊反搏患者中应用的Meta分析
CRD42023437577
Primary Review Question: "What are the benefits and risks associated with the use of anticoagulation in patients undergoing intra-aortic balloon pump (IABP) therapy?" Breaking this down into PICOS: Population: Patients u
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Record Fields
Scalar fields from the final meta_analysis record.
- Meta Analysis Id
- 7684
- Evidence Id
- 16242
- Core Evidence Id
- 16242
- Source Meta Analysis Id
- 7678
- Herb2 Meta Analysis Id
- HBMA007678
- Crd Id
- CRD42023437577
- Title
- Balancing Benefits and Risks: A Meta-Analysis on the Use of Heparin in IABP Patients
- Review Question
- Primary Review Question: "What are the benefits and risks associated with the use of anticoagulation in patients undergoing intra-aortic balloon pump (IABP) therapy?" Breaking this down into PICOS: Population: Patients undergoing IABP therapy Intervention: Use of anticoagulation Comparison: Patients not using anticoagulation Outcome: Safety outcomes (such as bleeding complications, thromboembolic events, etc.) and benefits (e.g., survival, reduced complications, improvement in cardiac function, etc.) Study type: Randomized controlled trials, observational studies
- Study Type Included
- The types of studies to be included in this review are as follows: Inclusion criteria: Randomized controlled trials (RCTs) Cohort studies (both prospective and retrospective) Case-control studies These study types are included as they can provide robust evidence on the benefits and risks associated with the use of anticoagulation in patients undergoing intra-aortic balloon pump (IABP) therapy. Exclusion criteria: Case reports, case series with less than 10 patients, and cross-sectional studies Narrative reviews, systematic reviews, and meta-analyses (though these will be used for identifying potentially relevant original studies) Animal studies or in-vitro studies The exclusion of case reports, small case series, and cross-sectional studies is because these study designs typically do not allow for the assessment of causal relationships, which is necessary for answering the research question. Reviews and meta-analyses are excluded as primary data sources, but they will be used to identify additional original research studies.
- Condition Being Studied
- The condition being studied in this systematic review is the management of patients undergoing intra-aortic balloon pump (IABP) therapy. IABP is a type of mechanical circulatory support device that is often used in patients with severe heart conditions, such as cardiogenic shock, or those undergoing high-risk cardiac procedures. It helps to increase myocardial oxygen perfusion and decrease the workload of the heart. One of the considerations in the management of these patients is the use of anticoagulation to prevent thromboembolic complications, given that the presence of a foreign body (the balloon pump) in the aorta could potentially promote blood clot formation. However, the use of anticoagulation could also increase the risk of bleeding complications. The domain of this review is therefore the intersection of cardiology, specifically mechanical circulatory support and anticoagulation management. The review aims to determine the balance of benefits and risks with the use of anticoagulation in patients on IABP, providing guidance for clinicians on this aspect of patient management.
- Participant
- In this systematic review and meta-analysis, the participants being studied are patients undergoing intra-aortic balloon pump (IABP) therapy. Here are the inclusion and exclusion criteria: Inclusion criteria: Studies involving adult patients (aged 18 years and above) Patients undergoing IABP therapy for any indication (such as cardiogenic shock, high-risk percutaneous coronary intervention, complications of acute myocardial infarction, etc.) Studies that report on the use of anticoagulation (any type) in these patients Studies that report on safety outcomes (like bleeding complications, thromboembolic events, etc.) and/or benefits (such as survival, improvement in cardiac function, etc.) Exclusion criteria: Studies involving pediatric patients (less than 18 years old) Studies where patients are on other forms of mechanical circulatory support in addition to IABP (like ventricular assist devices, extracorporeal membrane oxygenation, etc.) Case reports, opinion articles, and reviews (only original research articles like randomized controlled trials and observational studies will be included) These criteria will help ensure that the review focuses on the relevant patient population and captures the necessary information about anticoagulation use in patients on IABP.
- Animal
- Human Disease Modelled
- Intervention
- Inclusion criteria: Any type of anticoagulant drug used during the course of IABP therapy, including, but not limited to, unfractionated heparin, low molecular weight heparin, direct oral anticoagulants (DOACs), and vitamin K antagonists. Exclusion criteria: Studies where anticoagulation is used for an indication other than IABP therapy. Studies where anticoagulation is initiated prior to the start of IABP or continued after the termination of IABP for reasons not related to IABP therapy. Studies where the type of anticoagulant used is not clearly specified.
- Comparator Control
- In this systematic review, the comparator or control group will be patients undergoing intra-aortic balloon pump (IABP) therapy who are not receiving anticoagulation. Inclusion criteria: Patients who are not receiving any form of anticoagulation during the course of IABP therapy. Exclusion criteria: Patients receiving antiplatelet therapy only (such as aspirin or clopidogrel) will be excluded from the comparator group, as antiplatelet therapy is distinct from anticoagulation. This comparator group will help evaluate the safety and benefit outcomes associated with the use of anticoagulation in IABP patients, as compared to those not receiving anticoagulation. Please note that some studies might use a different form of anticoagulation as a comparator (for example, comparing unfractionated heparin with low molecular weight heparin). These studies will still be included, as long as they meet the other inclusion criteria, and they could contribute valuable data to subgroup analyses.
- Main Outcome
- The main outcomes of this review will be as follows: 1. Safety outcomes: The primary safety outcome will be major bleeding events as defined by the Bleeding Academic Research Consortium (BARC) Type 3 or 5 criteria. This includes any bleeding event requiring transfusion, surgical intervention, causing permanent injury or death, or intracranial hemorrhage. 2. Benefit outcomes: The primary benefit outcome will be survival, as measured by all-cause mortality at the longest follow-up available in each study.
- Outcome Measure
- Additional Outcome
- In addition to the main outcomes, the following additional outcomes will be assessed in this review: Thromboembolic events: This includes any arterial or venous thromboembolic events such as deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, or peripheral arterial occlusion. Minor bleeding events: This will be defined as any bleeding event that does not meet the criteria for major bleeding as per the BARC definition. This could include minor hematomas, epistaxis, hematuria, or other minor bleeding events that do not require transfusion or surgical intervention. Length of hospital stay: This is defined as the number of days from admission to discharge, and it serves as a surrogate measure for the overall burden of the disease and its management on the patient and healthcare system. Re-admission rates: This is defined as the number of patients who had to be re-admitted to the hospital within 30 days of discharge due to complications related to IABP or anticoagulation therapy. These additional outcomes provide a more comprehensive picture of the impact of anticoagulation in patients undergoing IABP therapy, supplementing the data obtained from the main outcomes. They will be included in the review if they are reported in the included studies.
- Study Method
- Intervention, Meta-analysis, Systematic review
- Keyword
- Anticoagulants; Heparin; Humans; Intra-Aortic Balloon Pumping; Observational Studies as Topic; Randomized Controlled Trials as Topic; Risk Assessment; Thromboembolism
- Contact
- Moiz Ahmed [email protected]
- Organisational Affiliation
- NICVD
- Funding Source
- Nil
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Pakistan
- Review Stage
- Review Ongoing
- First Submission Date
- 2023-06-18
- Registration Date
- 2023-06-29
- Anticipated Start Date
- 2023-06-18
- Anticipated Completion Date
- 2023-08-31
- Title Cn
- 平衡获益与风险：肝素在主动脉内球囊反搏患者中应用的Meta分析
- Title En
- Balancing Benefits and Risks: A Meta-Analysis on the Use of Heparin in IABP Patients
- Bilingual Status
- complete