Clinical trial NCT05501964: Predictors and Outcomes of Time to Hemostasis After Cardiac Catheterization
Official title: Predictors and Outcomes of Time to Hemostasis Post Trans-femoral Cardiac Catheterization: a Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to hemostasis
timeFrame: 12 hours after percutaneous coronary intervention
measure: Pre-procedure predictor factors associated with change of the mean time to hemostasis
timeFrame: before percutaneous coronary intervention
measure: Intra-procedure- predictor factors associated with a change in the mean time to hemostasis
timeFrame: during percutaneous coronary intervention
measure: Trans-Femoral Arterial Sheath Removal Predictor factors associated with a change in the mean time to hemostasis
timeFrame: 12 hours after percutaneous coronary intervention "during arterial sheath removal"
measure: Rate of the vascular Access Complications occurrence
timeFrame: 12 hours after percutaneous coronary intervention "during arterial sheath removal"
measure: Rate of the vascular Access Complications occurrence
timeFrame: 6 hours after sheath removal
measure: Rate of the vascular Access Complications occurrence
timeFrame: 12 hours after sheath removal
measure: Rate of the vascular Access Complications occurrence
timeFrame: immediately before patient discharge from the hospital
Secondary outcomes:
measure: Groin pain
timeFrame: Immediately after femoral sheath removal
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Andalusia Private Hospital
city: Alexandria
country: Egypt
facility: German Heart Center
city: Alexandria
country: Egypt
facility: Mabaret Aalsafra hospital
city: Alexandria
country: Egypt
facility: Shark El-Madina Hospital
city: Alexandria
country: Egypt
facility: Smouha University hospital
Study officials:
affiliation: Alexandria University
name: Maha G Asal, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Eshrak S Hashem, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Wafaa H Awad, Phd
role: PRINCIPAL_INVESTIGATOR
References: