Predictors and Outcomes of Time to Hemostasis After Cardiac Catheterization

Acute Coronary Syndrome Clinical Trial

Official title:

Predictors and Outcomes of Time to Hemostasis Post Trans-femoral Cardiac Catheterization: a Multicenter Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05501964
• Other study ID #: 1552022
• Status: Recruiting
• Start date: August 15, 2022
• Est. completion date: March 2023

Study information

• Verified date: December 2022
• Source: Alexandria University
• Contact: Maha G Asal, Phd
• Phone: +2001091200413
• Email: maha-gamal[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Locations

Country	Name	City	State
Egypt	Andalusia private hospital	Alexandria
Egypt	German Heart Center	Alexandria
Egypt	International Cardiac Center	Alexandria
Egypt	Mabaret Aalsafra hospital	Alexandria
Egypt	Shark El-Madina Hospital	Alexandria
Egypt	Smouha University Hospital	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to hemostasis	The time frame (minutes) required for manual compression from the removal of sheath to achieve hemostasis	12 hours after percutaneous coronary intervention
Primary	Pre-procedure predictor factors associated with change of the mean time to hemostasis	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.	before percutaneous coronary intervention
Primary	Intra-procedure- predictor factors associated with a change in the mean time to hemostasis	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.	during percutaneous coronary intervention
Primary	Trans-Femoral Arterial Sheath Removal Predictor factors associated with a change in the mean time to hemostasis	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.	12 hours after percutaneous coronary intervention "during arterial sheath removal"
Primary	Rate of the vascular Access Complications occurrence	Complication rate as 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	12 hours after percutaneous coronary intervention "during arterial sheath removal"
Primary	Rate of the vascular Access Complications occurrence	Complication rate as 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	6 hours after sheath removal
Primary	Rate of the vascular Access Complications occurrence	Complication rate as 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	12 hours after sheath removal
Primary	Rate of the vascular Access Complications occurrence	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.	immediately before patient discharge from the hospital
Secondary	Groin pain	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"	Immediately after femoral sheath removal