Postprocedural Bed-Rest Strategies After Transfemoral Venous Interventions

NCT07807787 | Not Yet Recruiting DMC

• 1 other identifier: 2026-LHKY-078
• Study Type: interventional
• Target: 1,550
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 2.Can shorter periods of immobilization and bed rest improve patient comfort, reduce back pain and anxiety, and allow earlier mobilization?

Conditions

Venous Access; Endovascular Procedures; Early Ambulation; Femoral Vein

Keywords

Femoral venous access; Venous intervention; Bed rest; Early ambulation; Access-Site bleeding

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 24 hours after the procedure

Secondary Outcomes (9)

• General Comfort Questionnaire Score

  8 hours after the procedure

• Comfort Numeric Rating Scale Score

  8 hours after the procedure

• Puncture-Site Pain Score

  8 hours after the procedure

• Low Back Pain Score

  8 hours after the procedure

• Anxiety Score

  8 hours after the procedure

Study Arms (3)

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

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

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

Behavioral: 8-hour Immobilization and Bed Rest

Interventions

4-hour Immobilization and Bed Rest BEHAVIORAL

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.

4-hour group

8-hour Immobilization and Bed Rest BEHAVIORAL

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.

8-hour group

2-hour Immobilization and Bed Rest BEHAVIORAL

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.

2-hour group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Related Publications (10)

• 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.

  PMID: 29375108 BACKGROUND

• Rezaei-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.

  PMID: 19296949 BACKGROUND

• Arai 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.

  PMID: 32782639 BACKGROUND

• Natale 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.

  PMID: 31971899 BACKGROUND

• Mills 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.

  PMID: 39233396 BACKGROUND

• Chikata 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.

  PMID: 38795098 BACKGROUND

• Mills 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.

  PMID: 41711619 BACKGROUND

• Chair 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.

  PMID: 22366106 BACKGROUND

• Wang 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.

  PMID: 39076463 BACKGROUND

• Hermiller 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.

  PMID: 25740963 BACKGROUND

MeSH Terms

Interventions

Immobilization; Bed Rest

Intervention Hierarchy (Ancestors)

Investigative Techniques; Therapeutics

Study Officials

• Yingfeng Wu, MD, PhD

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingfeng Wu, MD, PhD

CONTACT

+86-10-69543901; wyfxgwk@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Beijing Luhe Hospital, Capital Medical University

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 8, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09