Predictors and Outcomes of Time to Hemostasis After Cardiac Catheterization

NCT ID: NCT05501964

Last Updated: 2024-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-15

Study Completion Date

2024-05-05

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Maha Gamal Ramadan Asal

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maha G Asal, Phd

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Eshrak S Hashem, Phd

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Wafaa H Awad, Phd

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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Andalusia Private Hospital

Alexandria, , Egypt

Site Status

German Heart Center

Alexandria, , Egypt

Site Status

Mabaret Aalsafra hospital

Alexandria, , Egypt

Site Status

Shark El-Madina Hospital

Alexandria, , Egypt

Site Status

Smouha University hospital

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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1552022

Identifier Type: -

Identifier Source: org_study_id

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