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

A Randomized Comparison of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis After Percutaneous Coronary Intervention

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

Study Overview

• Status: Withdrawn
• Conditions: Common Femoral Artery Injury; Other Vascular Adverse Event
• Intervention / Treatment: Device: Assiut Femoral Compression Device

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71526
    • Assiut university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Assiut Femoral Compression Device; Assiut Femoral Compression Devices (AFCD) is a femoral compression system, The pressure dome is situated over the vessel puncture site in the groin and applies a mechanical pressure over the vessel puncture site to induce hemostasis.; Other Names: AFCD
Placebo Comparator: Manual compression; The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols.	Device: Assiut Femoral Compression Device; Assiut Femoral Compression Devices (AFCD) is a femoral compression system, The pressure dome is situated over the vessel puncture site in the groin and applies a mechanical pressure over the vessel puncture site to induce hemostasis.; Other Names: AFCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-To-Ambulation (TTA), measured in hours	Ambulation was defined as patient standing and walking at least 6 meters (20 feet) without re-bleeding or significant oozing requiring manual compression	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
the absence of major adverse events on discharge	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.	24 post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success:	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".	5 minutes during application
Procedure success	This was defined as hemostasis achieved by the assigned method, without the occurrence of a closure-related major adverse event (MAE).	24 h post procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-To-Hemostasis (TTH), measured in minutes.	Hemostasis was defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma	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
Minor complications:	Any oozing (leakage of blood from the puncture site requiring digital pressure), ecchymosis (bleeding into subcutaneous tissue planes causing bluish-purple discoloration > 4cm in diameter), hematoma (non pulsatile mass > 1 cm in diameter), and infections treatable with oral antibiotics	24h post procedure
Patient discomfort:	was assessed based on a short form of the McGill Pain Questionnaire using a Present Pain Intensity (PPI) scale that rated pain from 0 (no pain) to 5 (excruciating).	within 10 minutes of device application
Vasovagal manifestations	(sweating, bradycardia, nausea and vomiting) were recorded.	within 10 minutes of device application
Time the patient is deemed eligible for hospital discharge	Time the patient is deemed eligible for hospital discharge based on the report of the attending resident	within 24 hours post procedure

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ayman K.M. Hassan, MD. PhD., Assiut University

Publications and helpful links

General Publications

• 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).

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: July 26, 2014
• First Submitted That Met QC Criteria: August 9, 2014
• First Posted (Estimate): August 12, 2014

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: coronary artery disease; manual compression; coronary intervention; Femoral compression device; arterial hemostasis
• Other Study ID Numbers: AFCD-03; AUH-03 (Other Identifier: Assiut University)