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| ID | Type | Description | Link |
|---|---|---|---|
| AUH-03 | Other Identifier | Assiut University |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assiut Femoral Compression Device | Active Comparator | 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. |
|
| Manual compression | Placebo Comparator | The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assiut Femoral Compression Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Patients were excluded from the study if the patient has
Any procedural complication included:
Arterial access other than the right or left femoral artery ,
Vascular perforation, thrombosis during procedure ,
Patients with high risk of puncture site complications as:
Uncontrolled hypertension at time of procedure (>180/>110).
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| Name | Affiliation | Role |
|---|---|---|
| Ayman K.M. Hassan, MD. PhD. | Assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University Hospitals | Asyut | 71526 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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). |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 5 minutes during application |
| 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 |
| 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 |
| 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 |
| Vasovagal manifestations | (sweating, bradycardia, nausea and vomiting) were recorded. | within 10 minutes of device application |
| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |