Clinical trial NCT04689451: Feasibility and Safety of Total Percutaneous Closure of Femoral Arterial Access Sites in the Veno-arterial ECMO Patients
Official title: A Trial to Compare the Feasibility and Safety of Total Percutaneous Closure of Femoral Arterial Access Sites in the Veno-arterial ECMO Patients With Surgical Arterial Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiogenic Shock
Extracorporeal Membrane Oxygenation
Myocarditis
Hypertension, Pulmonary
Pulmonary Embolism
Heart Arrest
Medication Overdoses
Keywords: decannulation
veno-arterial extracorporeal membrane oxygenation
ProGlide
vascular complications
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients who underwent VA-ECMO

Brief summary: The most frequent access site for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is the common femoral artery (CFA), using either an open or percutaneous technique. Currently, percutaneous closure devices for femoral arterial access sites are approved for use only when a 10-F or smaller sheath has been used. However, the availability of the Perclose ProGlide (Abbott Laboratories, Chicago, IL) device has now made it possible to perform percutaneous vessel closure after using larger sheaths.The preclose technique using Perclose ProGlide, has been widely used in endovascular procedures. In a prospective randomized study, complication rates at the access site were similar in patients who underwent total percutaneous access (including percutaneous arteriotomy closure) than in those who underwent surgical cutdown and subsequent surgical closure. Total percutaneous closure of femoral arterial access sites increases patient comfort and decreases the rate of wound infections and lymphatic fistulas.\[6,7\] Furthermore, patients are mobilized and discharged earlier following the use of closure devices than with compression alone. Despite the above observations, no data have been published regarding percutaneous closure of femoral artery access sites in patients who have undergone VA-ECMO. In this study, we evaluated the safety and feasibility of a percutaneous closure technique using Perclose ProGlide to close the CFA access site after VA-ECMO.


Eligibility criteria: Inclusion Criteria:

- The study included all patients who underwent VA-ECMO and in whom Perclose ProGlide was deployed to achieve hemostasis during closure of the CFA site.

Exclusion Criteria:

* Patients were excluded if 24 hour and 30-day follow-up data regarding the access sites and other clinical outcomes were not available.

Primary outcomes:
measure: Perclose technical success
timeFrame: 1day
measure: Primary device failure
timeFrame: 1day
Secondary outcomes:
measure: Access-related complications
timeFrame: up to 24 hours after closure and during 30 days of follow-up.
Other outcomes:
Locations:
Study officials:
References: