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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assiut University
Sponsor:
Collaborator:
Mechatronics Division of Mechanical Engineering, Faculty of Engineering, Assuit University
Information provided by (Responsible Party):
Ayman Khairy Mohamed Hassan, Assiut University
ClinicalTrials.gov Identifier:
NCT02214030
First received: July 26, 2014
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Common Femoral Artery Injury
Other Vascular Adverse Event
Device: Assiut Femoral Compression Device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis After Percutaneous Coronary Intervention

Further study details as provided by Assiut University:

Primary Outcome Measures:
  • Time-To-Ambulation (TTA), measured in hours [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Ambulation was defined as patient standing and walking at least 6 meters (20 feet) without re-bleeding or significant oozing requiring manual compression

  • the absence of major adverse events on discharge [ Time Frame: 24 post procedure ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Device success: [ Time Frame: 5 minutes during application ] [ Designated as safety issue: No ]
    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".

  • Procedure success [ Time Frame: 24 h post procedure ] [ Designated as safety issue: Yes ]
    This was defined as hemostasis achieved by the assigned method, without the occurrence of a closure-related major adverse event (MAE).


Other Outcome Measures:
  • Time-To-Hemostasis (TTH), measured in minutes. [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Hemostasis was defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma

  • Minor complications: [ Time Frame: 24h post procedure ] [ Designated as safety issue: Yes ]
    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

  • Patient discomfort: [ Time Frame: within 10 minutes of device application ] [ Designated as safety issue: Yes ]
    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).

  • Vasovagal manifestations [ Time Frame: within 10 minutes of device application ] [ Designated as safety issue: Yes ]
    (sweating, bradycardia, nausea and vomiting) were recorded.

  • Time the patient is deemed eligible for hospital discharge [ Time Frame: within 24 hours post procedure ] [ Designated as safety issue: No ]
    Time the patient is deemed eligible for hospital discharge based on the report of the attending resident


Estimated Enrollment: 400
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02214030

Contacts
Contact: ayman KM hassan, MD,PhD 0882413006 ext 002` aymankhairy11@gmail.com

Locations
Egypt
Assiut University Hospitals Recruiting
Assiut, Egypt, 71526
Contact: Ahmed Maklof, prof    0882413600 ext 002    amakhloufsalama@yahoo.com   
Principal Investigator: ayman K.M. Hassan, MD. PhD         
Sponsors and Collaborators
Assiut University
Mechatronics Division of Mechanical Engineering, Faculty of Engineering, Assuit University
Investigators
Principal Investigator: Ayman K.M. Hassan, MD. PhD. Assiut University
  More Information

No publications provided

Responsible Party: Ayman Khairy Mohamed Hassan, Dr., Assiut University
ClinicalTrials.gov Identifier: NCT02214030     History of Changes
Other Study ID Numbers: AFCD-03, AUH-03
Study First Received: July 26, 2014
Last Updated: August 14, 2014
Health Authority: Egypt: Ministry of Higher Education

Keywords provided by Assiut University:
Femoral compression device
manual compression
arterial hemostasis
coronary intervention
coronary artery disease

Additional relevant MeSH terms:
Wounds and Injuries
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014