Common Femoral Artery Injury Clinical Trial
Official title:
A Randomized Comparison of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis After Percutaneous Coronary Intervention
| Verified date | July 2021 |
| Source | Assiut University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Assiut University Hospitals | Assiut |
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University |
Egypt,
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).
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | Vasovagal manifestations | (sweating, bradycardia, nausea and vomiting) were recorded. | within 10 minutes of device application | |
| Other | 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 | |
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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 |