Efficacy Study of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|