Efficacy Study of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis
|ClinicalTrials.gov Identifier: NCT02214030|
Recruitment Status : Unknown
Verified August 2014 by Ayman Khairy Mohamed Hassan, Assiut University.
Recruitment status was: Recruiting
First Posted : August 12, 2014
Last Update Posted : August 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Common Femoral Artery Injury Other Vascular Adverse Event||Device: Assiut Femoral Compression Device||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Comparison of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis After Percutaneous Coronary Intervention|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
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.
- 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 ]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 ]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.
- Device success: [ Time Frame: 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".
- Procedure success [ Time Frame: 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).
- 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 ]Hemostasis was defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma
- Minor complications: [ Time Frame: 24h post procedure ]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 ]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 ](sweating, bradycardia, nausea and vomiting) were recorded.
- Time the patient is deemed eligible for hospital discharge [ Time Frame: within 24 hours post procedure ]Time the patient is deemed eligible for hospital discharge based on the report of the attending resident
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214030
|Contact: ayman KM hassan, MD,PhD||0882413006 ext firstname.lastname@example.org|
|Assiut University Hospitals||Recruiting|
|Assiut, Egypt, 71526|
|Contact: Ahmed Maklof, prof 0882413600 ext 002 email@example.com|
|Principal Investigator: ayman K.M. Hassan, MD. PhD|
|Principal Investigator:||Ayman K.M. Hassan, MD. PhD.||Assiut University|