Predictors and Outcomes of Time to Hemostasis After Cardiac Catheterization

NCT05501964 | Completed

• 1 other identifier: 1552022
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 5

Brief Summary

This study aims to:

1. 1.Assess the incidence of hemostasis failure after manual compression of trans-femoral arterial sheath post percutaneous coronary intervention.
2. 2.Assess the predictors of time to hemostasis achieved by manual compression for trans-femoral arterial sheath post percutaneous coronary intervention.
3. 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. 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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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"

• 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"

• 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

• 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

• 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 Outcomes (1)

• Groin pain

  Immediately after femoral sheath removal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A sample size of 266 percutaneous coronary intervention patients is needed to detect the rate of complications after manual compression. Assuming the rate of complications according to a previous study was 4%, with an assumed population proportion of 8% using a two-sided, binomial hypothesis test with a target significance level of 0.05. Also, the sample size is sufficient to assess the meantime to homeostasis (26±15) min, with a precision of 4 min, according to a previous study, at a significance level of .05, using the One-sample t-test. The sample size was calculated using NCSS 2004 and PASS 2000 software.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (5)

Andalusia Private Hospital

Alexandria, Egypt

Location

German Heart Center

Alexandria, Egypt

Location

Mabaret Aalsafra hospital

Alexandria, Egypt

Location

Shark El-Madina Hospital

Alexandria, Egypt

Location

Smouha University hospital

Alexandria, Egypt

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Maha G Asal, Phd

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Eshrak S Hashem, Phd

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Wafaa H Awad, Phd

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 16, 2022
• Study Start: August 15, 2022
• Primary Completion: May 5, 2024
• Study Completion: May 5, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

EG (5)