[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"femoral-vein\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:femoral-vein":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100655108","postprocedural-bed-rest-strategies-after-transfemoral-venous-interventions-100655108",false,"NCT07807787","Postprocedural Bed-Rest Strategies After Transfemoral Venous Interventions","Comparison of 2-, 4-, and 8-Hour Postprocedural Immobilization and Bed-Rest Strategies After Transfemoral Venous Interventions: A Multicenter Randomized Controlled Trial","TVI-COMFORT","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. No clinically significant neurological or cognitive impairment, and no pre-existing condition causing substantial limitation of lower-extremity mobility before the procedure.\n3. Undergoing at least one of the following peripheral venous interventional procedures via femoral venous access, with postprocedural hemostasis achieved by manual compression: Lower-extremity venography alone; Inferior vena cava filter placement; Iliac vein stent placement; Endovascular thrombus removal for lower-extremity deep vein thrombosis; Other peripheral venous interventions using a 5-12 F sheath, including balloon angioplasty alone, pelvic vein embolization, or renal vein stent placement.\n4. Able to understand the purpose and procedures of the study, provide written informed consent, and comply with the study procedures and follow-up.\n\nExclusion Criteria:\n\n1. Concomitant ipsilateral femoral arterial access during the index procedure or inadvertent percutaneous puncture of the femoral artery.\n2. Visible access-site hematoma, persistent bleeding or oozing, pseudoaneurysm, or arteriovenous fistula occurring during femoral venous puncture or after sheath removal before randomization.\n3. Requirement for additional non-protocol anticoagulation after the procedure, or any foreseeable condition preventing adherence to the assigned immobilization and bed-rest schedule or completion of the scheduled assessments.\n4. Planned repeat puncture in the femoral region during the observation period or requirement for continued placement of a large-bore vascular sheath.\n5. Use of thrombolytic agents during the procedure or requirement for continued intravenous thrombolytic therapy after the procedure.\n6. Severe obesity or other conditions that make effective manual compression of the femoral access site difficult.\n7. Hemodynamic instability identified before randomization.\n8. Severe cardiac, hepatic, or renal insufficiency. Severe hepatic insufficiency is defined as alanine aminotransferase (ALT) \\>2 times the upper limit of normal or aspartate aminotransferase (AST) \\>2 times the upper limit of normal. Severe renal insufficiency is defined as serum creatinine \\>1.5 times the upper limit of normal or estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73 m².\n9. Clinically significant coagulation abnormality, including a platelet count \\\u003C100 × 10\\^9\u002FL.\n10. General anesthesia used during the index procedure.","ALL","18 Years",{"count":20,"type":21},1550,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to determine whether shorter periods of immobilization and bed rest after femoral venous interventional procedures can be safely used in adult patients undergoing peripheral venous interventions through femoral venous access. The main questions it aims to answer are:\n\n1. Do shorter periods of immobilization and bed rest increase the risk of femoral venous access-site bleeding-related complications, including bleeding and hematoma?\n2. Can shorter periods of immobilization and bed rest improve patient comfort, reduce back pain and anxiety, and allow earlier mobilization?\n\nResearchers will compare three postprocedural management strategies: 2 hours, 4 hours, and 8 hours of total immobilization and bed rest, to evaluate their safety and effects on patient recovery and comfort.\n\nParticipants will be randomly assigned to one of the following three groups:\n\n2-hour group: the puncture-side leg will be kept strictly immobilized for 0.5 hour, followed by 1.5 hours of bed rest.\n\n4-hour group: the puncture-side leg will be kept strictly immobilized for 2 hours, followed by 2 hours of bed rest.\n\n8-hour group: the puncture-side leg will be kept strictly immobilized for 4 hours, followed by 4 hours of bed rest.\n\nDuring strict immobilization, the puncture-side leg must remain extended and still. During the subsequent bed-rest period, small position adjustments and gentle movements in bed are allowed, but participants may not stand or walk.\n\nParticipants will be monitored for puncture-site bleeding and other complications and will complete assessments of comfort, pain, and anxiety after the procedure.",[27,28,29,30],"Venous Access","Endovascular Procedures","Early Ambulation","Femoral Vein",[32,33,34,35,36],"Femoral venous access","Venous intervention","Bed rest","Early ambulation","Access-Site bleeding","NOT_YET_RECRUITING","2026-09-03",{"date":40,"type":41},"2026-09-08","ACTUAL",{"date":43,"type":21},"2026-09-01",{"date":45,"type":21},"2027-10-15",{"name":47,"class":48},"Capital Medical University","OTHER"]