Venous AccessTVI-COMFORTNCT07807787
Postprocedural Bed-Rest Strategies After Transfemoral Venous Interventions
A study testing 2-hour Immobilization and Bed Rest, 4-hour Immobilization and Bed Rest and 8-hour Immobilization and Bed Rest in people with Venous Access and Endovascular Procedures, run by Capital Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Access, Endovascular Procedures, Early Ambulation
- What is being tested?
- 2-hour Immobilization and Bed Rest, 4-hour Immobilization and Bed Rest and 8-hour Immobilization and Bed Rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,550 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 15 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- No clinically significant neurological or cognitive impairment, and no pre-existing condition causing substantial limitation of lower-extremity mobility before the procedure.
- 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.
- Able to understand the purpose and procedures of the study, provide written informed consent, and comply with the study procedures and follow-up.
Who cannot join
- Concomitant ipsilateral femoral arterial access during the index procedure or inadvertent percutaneous puncture of the femoral artery.
- Visible access-site hematoma, persistent bleeding or oozing, pseudoaneurysm, or arteriovenous fistula occurring during femoral venous puncture or after sheath removal before randomization.
- 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.
- Planned repeat puncture in the femoral region during the observation period or requirement for continued placement of a large-bore vascular sheath.
- Use of thrombolytic agents during the procedure or requirement for continued intravenous thrombolytic therapy after the procedure.
- Severe obesity or other conditions that make effective manual compression of the femoral access site difficult.
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- Hemodynamic instability identified before randomization.
- 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.
- Clinically significant coagulation abnormality, including a platelet count <100 × 10^9/L.
- General anesthesia used during the index procedure.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
- Do shorter periods of immobilization and bed rest increase the risk of femoral venous access-site bleeding-related complications, including bleeding and hematoma?
- Can shorter periods of immobilization and bed rest improve patient comfort, reduce back pain and anxiety, and allow earlier mobilization?
Read more
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.
Read the detailed description
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.
- Conditions
- Venous Access, Endovascular Procedures, Early Ambulation, Femoral Vein
- Being tested
- 2-hour Immobilization and Bed Rest, 4-hour Immobilization and Bed Rest, 8-hour Immobilization and Bed Rest
- Keywords
- Femoral venous access, Venous intervention, Bed rest, Early ambulation, Access-Site bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-hour Immobilization and Bed RestBehavioural
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.
4-hour Immobilization and Bed RestBehavioural
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.
8-hour Immobilization and Bed RestBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 2-hour group | Experimental | In the 2-hour group, the affected leg will be kept immobilized for 0.5 hour followed by an additional 1.5 hours of bed rest Receives: Behavioral: 2-hour Immobilization and Bed Rest |
| 4-hour group | Experimental | In the 4-hour group, the affected leg will be kept immobilized for 2 hour followed by an additional 2 hours of bed rest Receives: Behavioral: 4-hour Immobilization and Bed Rest |
| 8-hour group | Active comparator | In the 8-hour group, the affected leg will be kept immobilized for 4 hour followed by an additional 4 hours of bed rest Receives: Behavioral: 8-hour Immobilization and Bed Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Access-Site Bleeding-Related Complications
Composite incidence of femoral venous access-site bleeding-related complications, including bleeding requiring repeat manual compression and access-site hematoma. Minor oozing requiring dressing change only will not be counted as an event. Hematomas will be assessed by ultrasound whenever feasible, with the maximum size recorded and categorized as <6 cm or ≥6 cm. Severe access-site complications include retroperitoneal bleeding; imaging-confirmed arteriovenous fistula or pseudoaneurysm; hematoma associated with a hemoglobin decrease ≥2 g/dL; bleeding or hematoma requiring blood transfusion; surgical or interventional radiology treatment; rehospitalization or prolongation of hospitalization by ≥24 hours due to an access-site complication; or symptomatic, imaging-confirmed access-related venous thrombosis.
Measured: Within 24 hours after the procedure
Secondary outcomes (9)
General Comfort Questionnaire Score
Participant comfort will be assessed using the Chinese version of the General Comfort Questionnaire (GCQ). The questionnaire contains 30 items covering physical, psychospiritual, sociocultural, and environmental dimensions of comfort. Each item is rated on a 4-point Likert scale, with appropriate reverse scoring for negatively worded items. Total scores range from 28 to 112, with higher scores indicating greater comfort.
Measured: 8 hours after the procedure
Comfort Numeric Rating Scale Score
Overall comfort will also be assessed using a Numeric Rating Scale (NRS) ranging from 1 to 10. Participants will rate their overall level of comfort, with 1 indicating the lowest level of comfort and 10 indicating the highest level of comfort. Higher scores indicate greater comfort.
Measured: 8 hours after the procedure
Puncture-Site Pain Score
Puncture-site pain will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Measured: 8 hours after the procedure
Low Back Pain Score
Low back pain will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Measured: 8 hours after the procedure
Anxiety Score
Anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A). Participants indicate their current level of anxiety on a 100-mm visual analog scale ranging from no anxiety to the highest level of anxiety. The score ranges from 0 to 100 mm, with higher scores indicating greater anxiety.
Measured: 8 hours after the procedure
Incidence of Analgesic Medication Use
The proportion of participants who receive any additional analgesic medication for postprocedural pain will be recorded.
Measured: Within 24 hours after the procedure
Incidence of Urinary Retention or Urinary Catheterization
The proportion of participants who develop urinary retention, defined as inability to void despite the urge to urinate and requiring clinical intervention, including placement of an indwelling urinary catheter when necessary, will be recorded.
Measured: Within 24 hours after the procedure
Incidence of Other Minor Access-Site Complications
The proportion of participants experiencing other minor femoral venous access-site complications will be recorded. These include minor puncture-site oozing not requiring repeat compression, subcutaneous ecchymosis, and local skin or soft-tissue infection around the puncture site.
Measured: Within 24 hours after the procedure
Incidence of Serious Access-Site Complications
Serious access-site complications include retroperitoneal bleeding; imaging-confirmed pseudoaneurysm or arteriovenous fistula; access-site hematoma associated with a hemoglobin decrease ≥2 g/dL; bleeding or hematoma requiring blood transfusion, surgical treatment, or interventional radiology treatment; prolongation of hospitalization by ≥24 hours due to an access-site complication; and symptomatic, imaging-confirmed access-related venous thrombosis.
Measured: From the end of the procedure through index hospital discharge, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Venous AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingfeng Wu, Capital Medical University
- Investigators
- Yingfeng Wu, MD, PhD, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807787
- Sponsor's protocol ID
- 2026-LHKY-078
- Acronym
- TVI-COMFORT
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Okada M, Inoue K, Tanaka K, Ninomiya Y, Hirao Y, Oka T, Tanaka N, Inoue H, Nakamaru R, Koyama Y, Okamura A, Iwakura K, Sakata Y, Fujii K. Efficacy and Safety of Figure-of-Eight Suture for Hemostasis After Radiofrequency Catheter Ablation for Atrial Fibrillation. Circ J. 2018 Mar 23;82(4):956-964. doi: 10.1253/circj.CJ-17-1213. Epub 2018 Jan 26.
PubMed 29375108Rezaei-Adaryani M, Ahmadi F, Asghari-Jafarabadi M. The effect of changing position and early ambulation after cardiac catheterization on patients' outcomes: a single-blind randomized controlled trial. Int J Nurs Stud. 2009 Aug;46(8):1047-53. doi: 10.1016/j.ijnurstu.2009.02.004. Epub 2009 Mar 17.
PubMed 19296949Arai H, Mizukami A, Hanyu Y, Kawakami T, Shimizu Y, Hiroki J, Yoshioka K, Otani H, Kuroda S, Iwatsuka R, Ueshima D, Hayashi T, Matsumura A, Goya M, Sasano T. Risk factors for venous bleeding complication at the femoral puncture site after catheter ablation of atrial fibrillation. J Arrhythm. 2020 Jun 1;36(4):678-684. doi: 10.1002/joa3.12378. eCollection 2020 Aug.
PubMed 32782639Natale A, Mohanty S, Liu PY, Mittal S, Al-Ahmad A, De Lurgio DB, Horton R, Spear W, Bailey S, Bunch J, Musat D, O'Neill P, Compton S, Turakhia MP; AMBULATE Trial Investigators. Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures: The AMBULATE Trial. JACC Clin Electrophysiol. 2020 Jan;6(1):111-124. doi: 10.1016/j.jacep.2019.08.013. Epub 2019 Oct 30.
PubMed 31971899Mills MT, Calvert P, Snowdon R, Mahida S, Waktare J, Borbas Z, Ashrafi R, Todd D, Modi S, Luther V, Gupta D. Suture-based techniques versus manual compression for femoral venous haemostasis after electrophysiology procedures. J Cardiovasc Electrophysiol. 2024 Nov;35(11):2119-2127. doi: 10.1111/jce.16417. Epub 2024 Sep 4.
PubMed 39233396Chikata A, Kato T, Usuda K, Fujita S, Usuda K, Maruyama M, Otowa KI, Kusayama T, Tsuda T, Hayashi K, Takamura M. Preclose Versus Postclose Using Suture-Mediated Vascular Closure System for Catheter Ablation With Femoral Vein Access. JACC Clin Electrophysiol. 2024 Aug;10(8):1828-1836. doi: 10.1016/j.jacep.2024.03.033. Epub 2024 May 22.
PubMed 38795098Mills MT, Calvert P, Tidbury L, Wilson K, Evans T, de Francesco L, Najm A, Tripathi R, Farinha JM, Xydis P, Thu K, Snowdon R, Borbas Z, Waktare J, Mahida SN, Denham N, Ashrafi R, Todd D, Modi S, Luther V, Gupta D. Figure-of-8 Suture With a 3-Way Tap Versus Manual Compression After Atrial Fibrillation Ablation: The HARNESS Randomized Controlled Trial. JACC Clin Electrophysiol. 2026 Jun;12(6):1316-1330. doi: 10.1016/j.jacep.2026.01.014. Epub 2026 Feb 19.
PubMed 41711619Chair SY, Yu M, Choi KC, Wong EM, Sit JW, Ip WY. Effect of early ambulation after transfemoral cardiac catheterization in Hong Kong: a single-blinded randomized controlled trial. Anadolu Kardiyol Derg. 2012 May;12(3):222-30. doi: 10.5152/akd.2012.065. Epub 2012 Feb 24.
PubMed 22366106Wang J, Cui J, Tu S, Li Q, Wang Y, Zhao L, Chen Z, Bao Y. Early Mobilization after Cardiac Catheterization via Femoral Artery: A Systematic Review and Meta-Analysis. Rev Cardiovasc Med. 2024 Apr 30;25(5):152. doi: 10.31083/j.rcm2505152. eCollection 2024 May.
PubMed 39076463Hermiller JB, Leimbach W, Gammon R, Karas SP, Whitbourn RJ, Wong SC, Goswami N, McCabe J, Cavros NG, Paulus R, Naidu SS, Turi ZG. A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients. J Invasive Cardiol. 2015 Mar;27(3):129-36.
PubMed 25740963
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 2-, 4-, and 8-Hour Postprocedural Immobilization and Bed-Rest Strategies After Transfemoral Venous Interventions: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07807787
- Acronym / sponsor ID
- TVI-COMFORT / 2026-LHKY-078
- Conditions
- Venous Access, Endovascular Procedures, Early Ambulation, Femoral Vein
- Keywords
- Femoral venous access, Venous intervention, Bed rest, Early ambulation, Access-Site bleeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,550 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do shorter periods of immobilization and bed rest increase the risk of femoral venous access-site bleeding-related complications, including bleeding and hematoma?
- 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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2-hour group | Experimental | Behavioral: 2-hour Immobilization and Bed RestIn the 2-hour group, the affected leg will be kept immobilized for 0.5 hour followed by an additional 1.5 hours of bed rest |
| 4-hour group | Experimental | Behavioral: 4-hour Immobilization and Bed RestIn the 4-hour group, the affected leg will be kept immobilized for 2 hour followed by an additional 2 hours of bed rest |
| 8-hour group | Active comparator | Behavioral: 8-hour Immobilization and Bed RestIn the 8-hour group, the affected leg will be kept immobilized for 4 hour followed by an additional 4 hours of bed rest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- No clinically significant neurological or cognitive impairment, and no pre-existing condition causing substantial limitation of lower-extremity mobility before the procedure.
- 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.
- Able to understand the purpose and procedures of the study, provide written informed consent, and comply with the study procedures and follow-up.
Key exclusion criteria (10 listed)
- Concomitant ipsilateral femoral arterial access during the index procedure or inadvertent percutaneous puncture of the femoral artery.
- Visible access-site hematoma, persistent bleeding or oozing, pseudoaneurysm, or arteriovenous fistula occurring during femoral venous puncture or after sheath removal before randomization.
- 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.
- Planned repeat puncture in the femoral region during the observation period or requirement for continued placement of a large-bore vascular sheath.
- Use of thrombolytic agents during the procedure or requirement for continued intravenous thrombolytic therapy after the procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-hour Immobilization and Bed RestParticipants 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. | Behavioural | 2-hour group |
| 4-hour Immobilization and Bed RestParticipants 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. | Behavioural | 4-hour group |
| 8-hour Immobilization and Bed RestParticipants 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. | Behavioural | 8-hour group |
Primary outcome
Incidence of Access-Site Bleeding-Related Complications
Time frame: Within 24 hours after the procedure
Composite incidence of femoral venous access-site bleeding-related complications, including bleeding requiring repeat manual compression and access-site hematoma. Minor oozing requiring dressing change only will not be counted as an event. Hematomas will be assessed by ultrasound whenever feasible, with the maximum size recorded and categorized as <6 cm or ≥6 cm. Severe access-site complications include retroperitoneal bleeding; imaging-confirmed arteriovenous fistula or pseudoaneurysm; hematoma associated with a hemoglobin decrease ≥2 g/dL; bleeding or hematoma requiring blood transfusion; surgical or interventional radiology treatment; rehospitalization or prolongation of hospitalization by ≥24 hours due to an access-site complication; or symptomatic, imaging-confirmed access-related venous thrombosis.
9 secondary outcomes
General Comfort Questionnaire Score
Time frame: 8 hours after the procedure
Comfort Numeric Rating Scale Score
Time frame: 8 hours after the procedure
Puncture-Site Pain Score
Time frame: 8 hours after the procedure
Low Back Pain Score
Time frame: 8 hours after the procedure
Anxiety Score
Time frame: 8 hours after the procedure
Incidence of Analgesic Medication Use
Time frame: Within 24 hours after the procedure
Incidence of Urinary Retention or Urinary Catheterization
Time frame: Within 24 hours after the procedure
Incidence of Other Minor Access-Site Complications
Time frame: Within 24 hours after the procedure
Incidence of Serious Access-Site Complications
Time frame: From the end of the procedure through index hospital discharge, an average of 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 29375108Okada M, Inoue K, Tanaka K, Ninomiya Y, Hirao Y, Oka T, Tanaka N, Inoue H, Nakamaru R, Koyama Y, Okamura A, Iwakura K, Sakata Y, Fujii K. Efficacy and Safety of Figure-of-Eight Suture for Hemostasis After Radiofrequency Catheter Ablation for Atrial Fibrillation. Circ J. 2018 Mar 23;82(4):956-964. doi: 10.1253/circj.CJ-17-1213. Epub 2018 Jan 26.
- Background: PubMed 19296949Rezaei-Adaryani M, Ahmadi F, Asghari-Jafarabadi M. The effect of changing position and early ambulation after cardiac catheterization on patients' outcomes: a single-blind randomized controlled trial. Int J Nurs Stud. 2009 Aug;46(8):1047-53. doi: 10.1016/j.ijnurstu.2009.02.004. Epub 2009 Mar 17.
- Background: PubMed 32782639Arai H, Mizukami A, Hanyu Y, Kawakami T, Shimizu Y, Hiroki J, Yoshioka K, Otani H, Kuroda S, Iwatsuka R, Ueshima D, Hayashi T, Matsumura A, Goya M, Sasano T. Risk factors for venous bleeding complication at the femoral puncture site after catheter ablation of atrial fibrillation. J Arrhythm. 2020 Jun 1;36(4):678-684. doi: 10.1002/joa3.12378. eCollection 2020 Aug.
- Background: PubMed 31971899Natale A, Mohanty S, Liu PY, Mittal S, Al-Ahmad A, De Lurgio DB, Horton R, Spear W, Bailey S, Bunch J, Musat D, O'Neill P, Compton S, Turakhia MP; AMBULATE Trial Investigators. Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures: The AMBULATE Trial. JACC Clin Electrophysiol. 2020 Jan;6(1):111-124. doi: 10.1016/j.jacep.2019.08.013. Epub 2019 Oct 30.
- Background: PubMed 39233396Mills MT, Calvert P, Snowdon R, Mahida S, Waktare J, Borbas Z, Ashrafi R, Todd D, Modi S, Luther V, Gupta D. Suture-based techniques versus manual compression for femoral venous haemostasis after electrophysiology procedures. J Cardiovasc Electrophysiol. 2024 Nov;35(11):2119-2127. doi: 10.1111/jce.16417. Epub 2024 Sep 4.
- Background: PubMed 38795098Chikata A, Kato T, Usuda K, Fujita S, Usuda K, Maruyama M, Otowa KI, Kusayama T, Tsuda T, Hayashi K, Takamura M. Preclose Versus Postclose Using Suture-Mediated Vascular Closure System for Catheter Ablation With Femoral Vein Access. JACC Clin Electrophysiol. 2024 Aug;10(8):1828-1836. doi: 10.1016/j.jacep.2024.03.033. Epub 2024 May 22.
- Background: PubMed 41711619Mills MT, Calvert P, Tidbury L, Wilson K, Evans T, de Francesco L, Najm A, Tripathi R, Farinha JM, Xydis P, Thu K, Snowdon R, Borbas Z, Waktare J, Mahida SN, Denham N, Ashrafi R, Todd D, Modi S, Luther V, Gupta D. Figure-of-8 Suture With a 3-Way Tap Versus Manual Compression After Atrial Fibrillation Ablation: The HARNESS Randomized Controlled Trial. JACC Clin Electrophysiol. 2026 Jun;12(6):1316-1330. doi: 10.1016/j.jacep.2026.01.014. Epub 2026 Feb 19.
- Background: PubMed 22366106Chair SY, Yu M, Choi KC, Wong EM, Sit JW, Ip WY. Effect of early ambulation after transfemoral cardiac catheterization in Hong Kong: a single-blinded randomized controlled trial. Anadolu Kardiyol Derg. 2012 May;12(3):222-30. doi: 10.5152/akd.2012.065. Epub 2012 Feb 24.
- Background: PubMed 39076463Wang J, Cui J, Tu S, Li Q, Wang Y, Zhao L, Chen Z, Bao Y. Early Mobilization after Cardiac Catheterization via Femoral Artery: A Systematic Review and Meta-Analysis. Rev Cardiovasc Med. 2024 Apr 30;25(5):152. doi: 10.31083/j.rcm2505152. eCollection 2024 May.
- Background: PubMed 25740963Hermiller JB, Leimbach W, Gammon R, Karas SP, Whitbourn RJ, Wong SC, Goswami N, McCabe J, Cavros NG, Paulus R, Naidu SS, Turi ZG. A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients. J Invasive Cardiol. 2015 Mar;27(3):129-36.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yingfeng Wu, MD, PhD principal investigator
Capital Medical University
Questions about this trial
What is this clinical trial studying?
A study testing 2-hour Immobilization and Bed Rest, 4-hour Immobilization and Bed Rest and 8-hour Immobilization and Bed Rest in people with Venous Access and Endovascular Procedures, run by Capital Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yingfeng Wu, MD, PhD (+86-10-69543901, wyfxgwk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Access-Site Bleeding-Related Complications (time frame: Within 24 hours after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07807787, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.