Femoral Arterial HemostasisFASTNCT04689555
Femoral Artery Hemostasis Without Manual Compression
A study testing Novel method without manual compression and Standard method with manual compression. in people with Femoral Arterial Hemostasis, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoral Arterial Hemostasis
- What is being tested?
- Novel method without manual compression and Standard method with manual compression.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing femoral access cardiovascular interventional therapy
- Patient must be competent for providing informed written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
About this study
Official title: Safety and Efficacy of Femoral Artery Hemostasis Without Manual Compression After Femoral Artery Puncture (FAST): a Prospective, Randomized, Open-label, Controlled, Multicenter Trial
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.
Read the 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.
- Conditions
- Femoral Arterial Hemostasis
- Being tested
- Novel method without manual compression, Standard method with manual compression.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel method without manual compressionProcedure or surgery
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.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Novel method without manual compression | Experimental | Not described Receives: Procedure: Novel method without manual compression |
| Standard method with manual compression | Active comparator | Not described Receives: Procedure: Standard method with manual compression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (3)
Time to hemostasis
From sheath removal to complete hemostasis
Measured: 1 month
Repeat manual compression
Need for repeated manual compression after end of closure procedure
Measured: 1 month
Total procedure time
From sheath removal to the end of the whole procedure
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Jan 2021
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Arterial HemostasisStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shenghua Zhou, Second Xiangya Hospital of Central South University
- Investigators
- Shenghua Zhou, Ph.D, Study chair, Second Xiangya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689555
- Sponsor's protocol ID
- FAST2020
- Acronym
- FAST
- Status last verified
- Apr 2023
- First submitted
- 24 Dec 2020
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Femoral Artery Hemostasis Without Manual Compression After Femoral Artery Puncture (FAST): a Prospective, Randomized, Open-label, Controlled, Multicenter Trial
- ClinicalTrials.gov ID
- NCT04689555
- Acronym / sponsor ID
- FAST / FAST2020
- Conditions
- Femoral Arterial Hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel method without manual compression | Experimental | Procedure: Novel method without manual compression |
| Standard method with manual compression | Active comparator | Procedure: Standard method with manual compression. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing femoral access cardiovascular interventional therapy
- Patient must be competent for providing informed written consent
Key exclusion criteria (8 listed)
- Peripheral arterial occlusive disease
- Prior peripheral artery surgery
- Critical limb ischemic
- Femoral arterial intubation failure
- Uncontrolled hypertension >220/110 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel method without manual compressionNovel 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. | Procedure or surgery | Novel method without manual compression |
| 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. | Procedure or surgery | Standard method with manual compression |
Primary outcome
Composite of arterial access related complications
Time frame: 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
3 secondary outcomes
Time to hemostasis
Time frame: 1 month
Repeat manual compression
Time frame: 1 month
Total procedure time
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shenghua Zhou, Ph.D study chair
Second Xiangya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel method without manual compression and Standard method with manual compression. in people with Femoral Arterial Hemostasis, run by Second Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of arterial access related complications (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.