Femoral Arterial Hemostasis
Conditions
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.
Interventions
PROCEDURENovel 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.
PROCEDUREStandard 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.
Sponsors
Second Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to hemostasis | 1 month | From sheath removal to complete hemostasis |
| Repeat manual compression | 1 month | Need for repeated manual compression after end of closure procedure |
| Total procedure time | 1 month | From sheath removal to the end of the whole procedure |
Countries
China
Outcome results
None listed