Preliminary Exploration of Factors Affecting Complete Hem... | NCT07469397

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

NCT07469397

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Mar 13, 2026Actual

Enrollment

157Estimated

Phase

Not provided

Conditions

Removal of Femoral Arterial Sheath in ICU Patients
Complete Hemostasis
Coronary Artery Disease
Percutaneous Coronary Intervention
Transcatheter Aortic Valve Implantation (TAVI)

Interventions

Direct Inspection, medical records browsing

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2025Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

May 13, 2025

First Submission Date that Met QC Criteria

Mar 10, 2026

First Posted Date

Mar 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2026

Last Update Posted Date

Mar 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

157Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Direct Inspection, medical records browsing	Diagnostic Test	Inspect the puncture site directly and collect data from medical records.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	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).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
POU YUN WANG	Contact	0965729268		unique201001@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36256701	Background	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.
19463301	Background

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases