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NCT07807787

Postprocedural Bed-Rest Strategies After Transfemoral Venous Interventions

Sponsor: Capital Medical University

View on ClinicalTrials.gov

Summary

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: 1. Do shorter periods of immobilization and bed rest increase the risk of femoral venous access-site bleeding-related complications, including bleeding and hematoma? 2. Can shorter periods of immobilization and bed rest improve patient comfort, reduce back pain and anxiety, and allow earlier mobilization? Researchers 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. Participants will be randomly assigned to one of the following three groups: 2-hour group: the puncture-side leg will be kept strictly immobilized for 0.5 hour, followed by 1.5 hours of bed rest. 4-hour group: the puncture-side leg will be kept strictly immobilized for 2 hours, followed by 2 hours of bed rest. 8-hour group: the puncture-side leg will be kept strictly immobilized for 4 hours, followed by 4 hours of bed rest. During 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. Participants will be monitored for puncture-site bleeding and other complications and will complete assessments of comfort, pain, and anxiety after the procedure.

Official title: Comparison of 2-, 4-, and 8-Hour Postprocedural Immobilization and Bed-Rest Strategies After Transfemoral Venous Interventions: A Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1550

Start Date

2026-09-01

Completion Date

2027-10-15

Last Updated

2026-09-08

Healthy Volunteers

Conditions

Venous Access Endovascular Procedures Early Ambulation Femoral Vein

Interventions

BEHAVIORAL

2-hour Immobilization and Bed Rest

Participants will undergo 0.5 hour of strict immobilization followed by 1.5 hours of bed rest. During immobilization, the puncture-side lower limb will remain fully extended and still. During subsequent bed rest, small position adjustments and gentle movements in bed are permitted, but standing, weight bearing, and ambulation are not allowed.

BEHAVIORAL

4-hour Immobilization and Bed Rest

Participants will undergo 2 hours of strict immobilization followed by 2 hours of bed rest. During immobilization, the puncture-side lower limb will remain fully extended and still. During subsequent bed rest, small position adjustments and gentle movements in bed are permitted, but standing, weight bearing, and ambulation are not allowed.

BEHAVIORAL

8-hour Immobilization and Bed Rest

Participants will undergo 4 hours of strict immobilization followed by 4 hours of bed rest. During immobilization, the puncture-side lower limb will remain fully extended and still. During subsequent bed rest, small position adjustments and gentle movements in bed are permitted, but standing, weight bearing, and ambulation are not allowed.

Inclusion Criteria: 1. Age ≥18 years. 2. No clinically significant neurological or cognitive impairment, and no pre-existing condition causing substantial limitation of lower-extremity mobility before the procedure. 3. 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. 4. Able to understand the purpose and procedures of the study, provide written informed consent, and comply with the study procedures and follow-up. Exclusion Criteria: 1. Concomitant ipsilateral femoral arterial access during the index procedure or inadvertent percutaneous puncture of the femoral artery. 2. Visible access-site hematoma, persistent bleeding or oozing, pseudoaneurysm, or arteriovenous fistula occurring during femoral venous puncture or after sheath removal before randomization. 3. 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. 4. Planned repeat puncture in the femoral region during the observation period or requirement for continued placement of a large-bore vascular sheath. 5. Use of thrombolytic agents during the procedure or requirement for continued intravenous thrombolytic therapy after the procedure. 6. Severe obesity or other conditions that make effective manual compression of the femoral access site difficult. 7. Hemodynamic instability identified before randomization. 8. 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) \<45 mL/min/1.73 m². 9. Clinically significant coagulation abnormality, including a platelet count \<100 × 10\^9/L. 10. General anesthesia used during the index procedure.

Clinical Research Directory

Postprocedural Bed-Rest Strategies After Transfemoral Venous Interventions

Summary

Key Details

Conditions

Interventions

Eligibility Criteria