The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
NCT Number: NCT04689555
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.
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Interventional
Not applicable
Changsha, Hunan, 410011, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
Time frame: 1 month
Composite of arterial access related complications, defined as the composite of:
Time frame: 1 month
From sheath removal to complete hemostasis
Time frame: 1 month
Need for repeated manual compression after end of closure procedure
Time frame: 1 month
From sheath removal to the end of the whole procedure
Second Xiangya Hospital of Central South University
Other
Safety and Efficacy of Femoral Artery Hemostasis Without Manual Compression After Femoral Artery Puncture (FAST): a Prospective, Randomized, Open-label, Controlled, Multicenter Trial
Acronym: FAST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.