Femoral Artery Hemostasis Without Manual Compression

Not Applicable

Completed

• Conditions: Femoral Arterial Hemostasis
• Interventions: Procedure: Standard method with manual compression.; Procedure: Novel method without manual compression

• Registration Number: NCT04689555
• Lead Sponsor: Second Xiangya Hospital of Central South University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-12-24
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-30
• Study Start: 2021-01-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard method with manual compression	Standard method with manual compression.	-
Novel method without manual compression	Novel method without manual compression	-

Primary Outcome Measures

Name	Time	Method
Composite of arterial access related complications	1 month	Composite of arterial access related complications, defined as the composite of: * Rate of ipsilateral groin hematomas with largest diameter exceeding 5 cm; * Pseudoaneurysm; * AV-Fistula; * Major bleeding; * Critical limb ischemia; * Local infection; * Need for vascular surgical or interventional treatment

Secondary Outcome Measures

Name	Time	Method
Total procedure time	1 month	From sheath removal to the end of the whole procedure
Repeat manual compression	1 month	Need for repeated manual compression after end of closure procedure
Time to hemostasis	1 month	From sheath removal to complete hemostasis

Trial Locations

Locations (1)

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China