Efficacy Study of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis

Not Applicable

Withdrawn

• Conditions: Other Vascular Adverse Event; Common Femoral Artery Injury
• Interventions: Device: Assiut Femoral Compression Device

• Registration Number: NCT02214030
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-07-26
• Study First Submitted QC: 2014-08-09
• Study First Posted: 2014-08-12
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Assiut Femoral Compression Device	Assiut Femoral Compression Device	the sheaths were removed 2 hours after PCI instead of conventional 6hours. 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 over the ensuing 8 minutes. Therefore 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.
Manual compression	Assiut Femoral Compression Device	The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols.

Primary Outcome Measures

Name	Time	Method
the absence of major adverse events on discharge	24 post procedure	major adverse event (MAE) was defined as symptomatic bleeding associated with hemoglobin drop ≥5 g/dL requiring blood transfusion, fatal bleeding that directly results in death, a pseudoaneurysm or arteriovenous fistula, distal arterial embolism, infections requiring administration of IV antibiotics or debridement, and the need for vascular surgery.
Time-To-Ambulation (TTA), measured in hours	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	Ambulation was defined as patient standing and walking at least 6 meters (20 feet) without re-bleeding or significant oozing requiring manual compression

Secondary Outcome Measures

Name	Time	Method
Procedure success	24 h post procedure	This was defined as hemostasis achieved by the assigned method, without the occurrence of a closure-related major adverse event (MAE).
Device success:	5 minutes during application	This was defined as easy application of the device with good fixation and stability and achieving final hemostasis. Device Stability was defined as absence of tilt and/or mobility after application of the device on top of the patient groin. Assessment of the device application was performed using a questionnaire with a scale of three grades; "Easy", "Difficult" and "Requires Improvement". Assessment of stability and fixation of the device was performed on a scale defined as "Very Good", "Good" and "Bad".

Trial Locations

Locations (1)

Assiut University Hospitals; 🇪🇬 Assiut, Egypt