Preliminary Exploration of Factors Affecting Complete Hemostasis and Supine Time After Removal of Femoral Arterial Sheath in ICU Patients

March 10, 2026 updated by: National Taiwan University Hospital

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  1. Patients admitted to the cardiac intensive care unit of this institution
  2. Patients requiring femoral arterial sheath removal

Description

Inclusion Criteria:

  1. Patients admitted to the cardiac intensive care unit of this hospital.
  2. Patients undergoing femoral arterial sheath removal.
  3. Age 20 years or older.

Exclusion Criteria:

  1. Patients unable to maintain supine position or refusing physical restraints.
  2. Patients with severe hematoma, vascular rupture, or other vascular complications present at the femoral arterial puncture site at the time of sheath insertion.
  3. Patients with a diagnosis of severe disseminated intravascular coagulation (DIC).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To understand the factors influencing complete hemostasis and supine duration after femoral arterial sheath removal in ICU patients.
Time Frame: 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).
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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 13, 2025

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202407183RINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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