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

NCT ID: NCT02214030

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2018-12-31

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.

Conditions

Common Femoral Artery Injury; Other Vascular Adverse Event

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Assiut Femoral Compression Device

Intervention Type: 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.

Manual compression

The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols.

Group Type: PLACEBO_COMPARATOR

Assiut Femoral Compression Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

AFCD

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ayman khairy Mohamed

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayman K.M. Hassan, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut University Hospitals

Asyut, , Egypt

Countries

Egypt

References

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).

Reference Type: BACKGROUND

Other Identifiers

AUH-03

Identifier Type: OTHER

Identifier Source: secondary_id

AFCD-03

Identifier Type: -

Identifier Source: org_study_id