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Completed

NCT Number: NCT05501964

Predictors and Outcomes of Time to Hemostasis After Cardiac Catheterization

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andalusia Private Hospital, Alexandria, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to hemostasis

    Time frame: 12 hours after percutaneous coronary intervention

    The time frame (minutes) required for manual compression from the removal of sheath to achieve hemostasis

  2. Pre-procedure predictor factors associated with change of the mean time to hemostasis

    Time frame: 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.

  3. Intra-procedure- predictor factors associated with a change in the mean time to hemostasis

    Time frame: 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.

  4. Trans-Femoral Arterial Sheath Removal Predictor factors associated with a change in the mean time to hemostasis

    Time frame: 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.

  5. Rate of the vascular Access Complications occurrence

    Time frame: 12 hours after percutaneous coronary intervention "during arterial sheath removal"

    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. Rate of the vascular Access Complications occurrence

    Time frame: 6 hours after sheath removal

    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

  7. Rate of the vascular Access Complications occurrence

    Time frame: 12 hours after sheath removal

    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

  8. Rate of the vascular Access Complications occurrence

    Time frame: 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 outcomes

  1. Groin pain

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2022
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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