Femoral Artery Hemostasis Without Manual Compression

Study Overview
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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.

Official Title
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Safety and Efficacy of Femoral Artery Hemostasis Without Manual Compression After Femoral Artery Puncture (FAST): a Prospective, Randomized, Open-label, Controlled, Multicenter Trial

Conditions
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Femoral Arterial Hemostasis

Intervention / Treatment
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* Procedure: Novel method without manual compression
* Procedure: Standard method with manual compression.


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel method without manual compression<br> | Procedure: Novel method without manual compression<br>* 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.<br>|
| Active Comparator: Standard method with manual compression<br> | Procedure: Standard method with manual compression.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of arterial access related complications | 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 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemostasis | From sheath removal to complete hemostasis | 1 month | 
| Repeat manual compression | Need for repeated manual compression after end of closure procedure | 1 month | 
| Total procedure time | From sheath removal to the end of the whole procedure | 1 month |