Removal of Femoral Arterial Sheath in ICU PatientsNCT07469397
Preliminary Exploration of Factors Affecting Complete Hemostasis and Supine Time After Removal of Femoral Arterial Sheath in ICU Patients
An observational study of Removal of Femoral Arterial Sheath in ICU Patients and Complete Hemostasis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background:Following cardiac catheterization and arterial sheath removal, manual compression is applied until bleeding stops, after which a compression belt is used. Patients must lie supine for at least 6 hours, often experiencing discomfort including back pain, eating difficulties, and urinary problems. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Removal of Femoral Arterial Sheath in ICU Patients, Complete Hemostasis, Coronary Artery Disease
- What is being tested?
- Direct Inspection, medical records browsing
- How many people
- 157 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 May 2025to 31 Dec 2026
- Phase
- Observational
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients admitted to the cardiac intensive care unit of this institution 2. Patients requiring femoral arterial sheath removal
Who may be able to join
- Patients admitted to the cardiac intensive care unit of this hospital.
- Patients undergoing femoral arterial sheath removal.
- Age 20 years or older.
Who cannot join
- Patients unable to maintain supine position or refusing physical restraints.
- Patients with severe hematoma, vascular rupture, or other vascular complications present at the femoral arterial puncture site at the time of sheath insertion.
- Patients with a diagnosis of severe disseminated intravascular coagulation (DIC).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Pou yun Wang, 0965729268, unique201001@gmail.com
About this study
Background:Following cardiac catheterization and arterial sheath removal, manual compression is applied until bleeding stops, after which a compression belt is used. Patients must lie supine for at least 6 hours, often experiencing discomfort including back pain, eating difficulties, and urinary problems. The compressed leg is restrained to prevent movement, adding to the discomfort. Despite adhering to this standard procedure, some patients still develop bleeding or hematomas after compression, requiring extended treatment. Current research on predicting compression duration and bleeding risk factors after femoral arterial sheath removal is limited and inconsistent. This study aims to identify factors that can more accurately predict necessary compression time after initial hemostasis, potentially reducing patient discomfort and complications such as prolonged bleeding, extended compression, and hematoma formation, which can impact vital signs.
Purpose:To understand the factors influencing complete hemostasis and supine duration after femoral arterial sheath removal in ICU patients.
Read more
Methods:Clinical data were collected through observation, and statistical analysis was performed using SPSS.
Expected Outcomes:To identify factors that influence complete hemostasis and supine duration after femoral arterial sheath removal in ICU patients, and to develop a prediction model that allows clinical units to accurately assess the required supine compression time following femoral arterial sheath removal.
- Conditions
- Removal of Femoral Arterial Sheath in ICU Patients, Complete Hemostasis, Coronary Artery Disease, Percutaneous Coronary Intervention, Transcatheter Aortic Valve Implantation (TAVI)
- Being tested
- Direct Inspection, medical records browsing
- Keywords
- Complete Hemostasis, Supine Time
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Inspection, medical records browsingDiagnostic test
Inspect the puncture site directly and collect data from medical records.
What is being measured
The primary outcome is the main question the study is designed to answer.
To understand the factors influencing complete hemostasis and supine duration after femoral arterial sheath removal in ICU patients.
This study is a correlational study, and its main objective is to identify the factors associated with the inability to achieve complete hemostasis within the standard time (defined as 6 hours).
Measured: This study is a correlational study, and its main objective is to identify the factors associated with the inability to achieve complete hemostasis within the standard time (defined as 6 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start15 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Removal of Femoral Arterial Sheath in ICU PatientsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469397
- Sponsor's protocol ID
- 202407183RINE
- Status last verified
- Mar 2026
- First submitted
- 13 May 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Busca E, Airoldi C, Bertoncini F, Buratti G, Casarotto R, Gaboardi S, Faggiano F, Barisone M, White IR, Allara E, Dal Molin A. Bed rest duration and complications after transfemoral cardiac catheterization: a network meta-analysis. Eur J Cardiovasc Nurs. 2023 Jul 19;22(5):454-462. doi: 10.1093/eurjcn/zvac098.
PubMed 36256701Doyle BJ, Ting HH, Bell MR, Lennon RJ, Mathew V, Singh M, Holmes DR, Rihal CS. Major femoral bleeding complications after percutaneous coronary intervention: incidence, predictors, and impact on long-term survival among 17,901 patients treated at the Mayo Clinic from 1994 to 2005. JACC Cardiovasc Interv. 2008 Apr;1(2):202-9. doi: 10.1016/j.jcin.2007.12.006.
PubMed 19463301Marquis-Gravel G, Boivin-Proulx LA, Huang Z, Zelenkofske SL, Lincoff AM, Mehran R, Steg PG, Bode C, Alexander JH, Povsic TJ. Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention. J Am Heart Assoc. 2023 Jan 3;12(1):e025666. doi: 10.1161/JAHA.122.025666. Epub 2022 Dec 30.
PubMed 36583436Mohammady M, Atoof F, Sari AA, Zolfaghari M. Bed rest duration after sheath removal following percutaneous coronary interventions: a systematic review and meta-analysis. J Clin Nurs. 2014 Jun;23(11-12):1476-85. doi: 10.1111/jocn.12313. Epub 2013 Sep 13.
PubMed 24028631Olson NC. Comparison of Head Elevation Protocols Following Femoral Artery Sheath Removal After Coronary Angiography. Crit Care Nurse. 2016 Jun;36(3):20-34. doi: 10.4037/ccn2016560.
PubMed 27252099Reich R, Helal L, Mantovani VM, Rabelo-Silva ER. Hemostasis after percutaneous transfemoral access: A protocol for systematic review. Medicine (Baltimore). 2020 Dec 24;99(52):e23731. doi: 10.1097/MD.0000000000023731.
PubMed 33350755Santos VB, Melo LME, Assis ARV, Moraes JB, Lopes CT, Lopes JL, Barros ALBL. Decreasing length of limb immobilisation following nonelective transfemoral percutaneous coronary intervention: A randomised clinical trial. J Clin Nurs. 2019 Sep;28(17-18):3140-3148. doi: 10.1111/jocn.14860. Epub 2019 Apr 24.
PubMed 30938903Sulzbach-Hoke LM, Ratcliffe SJ, Kimmel SE, Kolansky DM, Polomano R. Predictors of complications following sheath removal with percutaneous coronary intervention. J Cardiovasc Nurs. 2010 May-Jun;25(3):E1-8. doi: 10.1097/JCN.0b013e3181c83f4b.
PubMed 20357666Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
PubMed 35078371