Clinical trial NCT02214030: Efficacy Study of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis
Official title: A Randomized Comparison of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis After Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Common Femoral Artery Injury
Other Vascular Adverse Event
Keywords: Femoral compression device
manual compression
arterial hemostasis
coronary intervention
coronary artery disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was performed to evaluate the safety and efficacy of a locally designed Assiut Femoral Compression Device (AFCD) versus manual compression (MC). Femoral compression devices have been developed thorough the past decades without being strongly implemented in the catheterization laboratory. Their limited adoption reflects concerns of high cost and conflicting data regarding their safety

Detailed description: The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols. However for AFCD group, the sheaths were removed 2 hours after PCI instead of conventional 6 hours. To standardize compression times, AFCD were applied to patient and complete femoral artery compression were applied for 5 minutes, followed by a gradual release of pressure till distal pulse is palpated. Each patient received a minimum of 13 minutes of compression, with further compression applied only if full hemostasis had not been achieved at that point with maximum of 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 85 years of age,
* Scheduled to undergo an elective PCI via arterial puncture of common femoral artery were eligible for enrollment in the study.
* Elective PCI was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned PCI or for a coronary angiogram followed by ad hoc PCI.

Exclusion Criteria:

Patients were excluded from the study if the patient has

1. Any procedural complication included:

   * prolonged chest pain,
   * transient coronary artery closure, no-flow or slow-flow phenomenon,
   * hemodynamic instability,
   * persistent electrocardiographic changes,
   * side-branch occlusion of \>1.5 mm, or
   * an angiographically suboptimal result,
2. Arterial access other than the right or left femoral artery ,
3. Vascular perforation, thrombosis during procedure ,
4. Patients with high risk of puncture site complications as:

   * Bleeding diathesis,
   * International normalized ratio \>1.5,
   * Recent thrombolysis,
   * Low platelet count,
   * Hematoma at the end of the procedure,
   * Previous iliofemoral artery surgery or any peripheral vascular Surgery,
   * Previous femoral artery complication from angiography, and
5. Uncontrolled hypertension at time of procedure (\>180/\>110).

Primary outcomes:
measure: Time-To-Ambulation (TTA), measured in hours
timeFrame: TTA was measured from the time the introducer sheath was removed (2 hr in AFCD group and 6 hours in MC group after end of PCI) to time of ambulation
measure: the absence of major adverse events on discharge
timeFrame: 24 post procedure
Secondary outcomes:
measure: Device success:
timeFrame: 5 minutes during application
measure: Procedure success
timeFrame: 24 h post procedure
Other outcomes:
measure: Time-To-Hemostasis (TTH), measured in minutes.
timeFrame: TTH was measured from the time the introducer sheath was removed (2 hr in AFCD group and 6 hours in MC group after end of PCI) to the time hemostasis was achieved
measure: Minor complications:
timeFrame: 24h post procedure
measure: Patient discomfort:
timeFrame: within 10 minutes of device application
measure: Vasovagal manifestations
timeFrame: within 10 minutes of device application
measure: Time the patient is deemed eligible for hospital discharge
timeFrame: within 24 hours post procedure
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals
Study officials:
affiliation: Assiut University
name: Ayman K.M. Hassan, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hassan AKM, Hasan-Ali H, Ali AS. A new femoral compression device compared with manual compression for bleeding control after coronary diagnostic catheterizations. The Egyptian Heart Journal. 2013 (in-press).