Predictors and Outcomes of Time to Hemostasis After Cardiac Catheterization

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT05501964
• Lead Sponsor: Alexandria University

Brief Summary

This study aims to:

1. Assess the incidence of hemostasis failure after manual compression of trans-femoral arterial sheath post percutaneous coronary intervention.

2. Assess the predictors of time to hemostasis achieved by manual compression for trans-femoral arterial sheath post percutaneous coronary intervention.

3. Assess the association between time to hemostasis and the incidence of vascular access complications after manual compression for trans-femoral arterial sheath removal post percutaneous coronary intervention.

4. Assess the association between failed hemostasis and the incidence of vascular access complications after manual compression for trans-femoral arterial sheath removal post percutaneous coronary intervention.

Detailed Description

Nurses and medical professionals have a vital role in detecting, preventing, and managing complications at the earliest possible stage. They should assess patients for high risk of complications, and plan management strategies to decrease those complications. In many acute and critical care settings, removing femoral sheaths and handling related complications after percutaneous coronary intervention. are primarily the responsibilities of nurses. Therefore, after catheterization procedures, assessing the predictors of required time to achieve optimal hemostasis at the time of trans-femoral arterial sheath removal is essential as one of the final modifiable measures to prevent access site complications. This study will be done in 6 Cardiac catheterization units representing governmental and private hospitals. A sample size of 266 patients will be recruited for the study. data will be analyzed by univariate and multivariate analysis.

Study Timeline

• Study First Submitted: 2022-08-06
• Study First Submitted QC: 2022-08-12
• Study Start: 2022-08-15
• Study First Posted: 2022-08-16
• Primary Completion: 2024-05-05
• Study Completion: 2024-05-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients who planned for elective or primary percutaneous coronary intervention with femoral access, and
• Agreed to participate in the study

Exclusion Criteria

• Patients who had trans-femoral catheterization procedure within a 1-month duration
• patients with a known history of coagulation disorders,
• patients with sheath removed at the laboratory, and
• Patients who experience post - catheterization life-threatening events rather than vascular access complications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intra-procedure- predictor factors associated with a change in the mean time to hemostasis	during percutaneous coronary intervention	Intra-procedure factors as measured by the percutaneous coronary intervention factors assessment checklist. This checklist will gather data regarding, puncture site, the number of punctures, guiding Catheter size, medications taken, procedure duration, amount of dye used, fluoroscopy time and the procedure done, and years of operator experience. These factors will be analyzed using multiple regression to identify intra-procedure predictor factors associated with a change in the mean hemostasis time.
Trans-Femoral Arterial Sheath Removal Predictor factors associated with a change in the mean time to hemostasis	12 hours after percutaneous coronary intervention "during arterial sheath removal"	Trans-Femoral Arterial Sheath Removal Variables checklist. This checklist gathers data regarding sheath removal time after the procedure, heart rate, and blood pressure before and after sheath removal, failed closure, ambulation time after sheath removal qualification, and years of experience of the health care provider who removes the sheath. These factors will be analyzed using multiple regression to identify trans-femoral arterial sheath removal factors associated with a change in the mean hemostasis time.
Time to hemostasis	12 hours after percutaneous coronary intervention	The time frame (minutes) required for manual compression from the removal of sheath to achieve hemostasis
Pre-procedure predictor factors associated with change of the mean time to hemostasis	before percutaneous coronary intervention	Patient and procedure-related factors will be assessed by patient demographics and clinical data questionnaire. This questionnaire will gather data regarding patient demographics, comorbidities, risk factors, blood chemistry medications taken, and angiographic factors that can predict the mean time to safe hemostasis.
Rate of the vascular Access Complications occurrence	immediately before patient discharge from the hospital	The complication rate will be assessed by the number of events for oozing, ecchymosis, hematoma, bleeding, pseudoaneurysm, arteriovenous fistula, and femoral occlusion as assessed by the assigned nurse and treating physician.

Secondary Outcome Measures

Name	Time	Method
Groin pain	Immediately after femoral sheath removal	Severity of the pain experienced by the patient as assessed by the pain Visual Analog Scale. the scale score range from 0-10. score of 0 indicate "no pain", 1-3 " mild pain", 4-6 "moderate pain", and 7-10 " severe pain"

Trial Locations

Locations (5)

Mabaret Aalsafra hospital; 🇪🇬 Alexandria, Egypt

Smouha University hospital; 🇪🇬 Alexandria, Egypt

German Heart Center; 🇪🇬 Alexandria, Egypt

Andalusia Private Hospital; 🇪🇬 Alexandria, Egypt

Shark El-Madina Hospital; 🇪🇬 Alexandria, Egypt