Femoral Artery Hemostasis Without Manual Compression

NCT ID: NCT04689555

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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FAST trial is a prospective, randomized, controlled, multicenter study in participants needing hemostasis after femoral arterial puncture. All eligible participants will be randomly assigned to either manual compression or novel method without manual compression after femoral arterial puncture. This study is aimed to investigate if novel method without manual compression is noninferior to manual compression regarding access site complications.

Detailed Description

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The common femoral artery is the most frequently used access site in cardiovascular interventional therapy. Closure of the arteriotomy site is usually achieved by manual compression after femoral arterial puncture. There are many disadvantages of this standard method for hemostasis which is still related to high rate of access-site complications such as pseudoaneurysm, major bleeding, ipsilateral groin hematomas and so on. Several vascular closure devices are emerging as novel means for improving patient comfort and accelerating ambulation after invasive cardiovascular procedures performed via femoral arterial access, however, the cost performance and other aspects limit its wide application especially in developing countries.

Actually the investigators found a novel method for femoral artery hemostasis without manual compression. After sheath removal, four or five sterile gauzes were overlaid layer by layer and then bandaged without the procedure of manual compression.

FAST trial is aimed to investigate if the safety and efficacy of this novel method without manual compression is noninferior to the standard manual compression.

Conditions

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Femoral Arterial Hemostasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Novel method without manual compression

Group Type EXPERIMENTAL

Novel method without manual compression

Intervention Type PROCEDURE

Novel method for femoral artery hemostasis without manual compression. After sheath removal, four or five sterile gauzes were overlaid layer by layer and then bandaged without the procedure of manual compression.

Standard method with manual compression

Group Type ACTIVE_COMPARATOR

Standard method with manual compression.

Intervention Type PROCEDURE

Standard method for femoral artery hemostasis with manual compression.After sheath removal, manual compression was continued for at least 10 minutes or until hemostasis. After that four or five sterile gauzes were overlaid layer by layer and then bandaged without the procedure of manual compression.

Interventions

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Novel method without manual compression

Novel method for femoral artery hemostasis without manual compression. After sheath removal, four or five sterile gauzes were overlaid layer by layer and then bandaged without the procedure of manual compression.

Intervention Type PROCEDURE

Standard method with manual compression.

Standard method for femoral artery hemostasis with manual compression.After sheath removal, manual compression was continued for at least 10 minutes or until hemostasis. After that four or five sterile gauzes were overlaid layer by layer and then bandaged without the procedure of manual compression.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing femoral access cardiovascular interventional therapy
* Patient must be competent for providing informed written consent

Exclusion Criteria

* Peripheral arterial occlusive disease
* Prior peripheral artery surgery
* Critical limb ischemic
* Femoral arterial intubation failure
* Uncontrolled hypertension \>220/110 mmHg
* Coagulopathy (bleeding disorder)
* Local infection
* Pregnancy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Shenghua Zhou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shenghua Zhou, Ph.D

Role: STUDY_CHAIR

Second Xiangya Hospital

Locations

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The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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FAST2020

Identifier Type: -

Identifier Source: org_study_id

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