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

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.

Percutaneous femoral venous access is widely used for peripheral venous interventional procedures, including lower-extremity venography, inferior vena cava filter placement, iliac vein stenting, and endovascular treatment of deep vein thrombosis. After sheath removal, hemostasis is commonly achieved by manual compression followed by application of a pressure dressing. Patients are subsequently required to keep the puncture-side lower limb immobilized and remain in bed for a period of time to reduce the risk of access-site bleeding. However, the optimal duration of immobilization and bed rest after femoral venous procedures has not been well established, and current practice varies considerably among institutions.

Evidence from transfemoral arterial and cardiac catheter-based procedures suggests that earlier mobilization may reduce discomfort, back pain, urinary difficulties, and anxiety without substantially increasing access-site bleeding. However, evidence specific to peripheral venous interventions remains limited. Femoral venous procedures differ from arterial and cardiac procedures in vascular anatomy, procedural characteristics, sheath size, and perioperative antithrombotic management. Therefore, dedicated evidence is needed to determine whether shorter periods of immobilization and bed rest can be safely implemented after femoral venous interventions.

This is a multicenter, randomized, open-label clinical trial with blinded outcome assessment. Adult participants undergoing eligible peripheral venous interventional procedures through femoral venous access and receiving manual compression followed by a pressure dressing for hemostasis will be randomly assigned in a 1:1:1 ratio to one of three postprocedural management strategies: 2 hours, 4 hours, or 8 hours of total immobilization and bed rest.

In the 2-hour group, the puncture-side lower limb will be strictly immobilized for 0.5 hour, followed by an additional 1.5 hours of bed rest. In the 4-hour group, strict immobilization will be maintained for 2 hours, followed by an additional 2 hours of bed rest. In the 8-hour group, strict immobilization will be maintained for 4 hours, followed by an additional 4 hours of bed rest. Strict immobilization is defined as remaining in bed with the puncture-side lower limb fully extended and kept still, without substantial hip or knee flexion or movement of the puncture-side limb. During the subsequent bed-rest period, strict limb immobilization is no longer required; small position adjustments and gentle movements in bed are permitted, but standing, weight bearing, and ambulation are not allowed. Participants may begin ambulation after completion of the assigned period if there is no active bleeding or other clinical condition requiring continued bed rest.

The primary outcome is the incidence of femoral venous access-site bleeding-related complications within 24 hours after the procedure, including access-site bleeding that requires repeat manual compression or other clinical management, and access-site hematoma. Minor oozing requiring dressing change only will not be counted as a primary outcome event. Hematoma size will be assessed by ultrasound whenever feasible. Prespecified serious access-site complications will also be monitored, including retroperitoneal bleeding, imaging-confirmed arteriovenous fistula or pseudoaneurysm, hematoma associated with a hemoglobin decrease of ≥2 g/dL, bleeding or hematoma requiring blood transfusion, surgical or interventional treatment, rehospitalization or prolongation of hospitalization by ≥24 hours because of an access-site complication, and symptomatic imaging-confirmed access-related venous thrombosis.

Secondary outcomes include patient comfort assessed at 8 hours using the General Comfort Questionnaire and a 0-to-10 Numeric Rating Scale, puncture-site pain and low back pain also assessed using Numeric Rating Scales, and anxiety assessed using a Visual Analog Scale for Anxiety. Additional outcomes assessed within 24 hours include use of analgesic or anxiolytic medications, urinary retention or requirement for urinary catheterization, and other minor access-site complications such as minor oozing, ecchymosis, and local infection.

The study is designed to determine whether shorter periods of postprocedural immobilization and bed rest can facilitate earlier mobilization and improve patient comfort while maintaining acceptable access-site safety. The findings are expected to provide evidence for the development of a more standardized and patient-centered postprocedural management strategy after peripheral venous interventions performed through femoral venous access.

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.