Acute Coronary SyndromeNCT05501964
Predictors and Outcomes of Time to Hemostasis After Cardiac Catheterization
An observational study of Acute Coronary Syndrome, run by Alexandria University at 5 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 300 participants
- Where
- 5 sitesEgypt
- Study dates
- 15 Aug 2022to 5 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients who planned for elective or primary percutaneous coronary intervention with femoral access, and
- Agreed to participate in the study
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Egypt5 sites
Andalusia Private Hospital
Alexandria
German Heart Center
Alexandria
Mabaret Aalsafra hospital
Alexandria
Shark El-Madina Hospital
Alexandria
Smouha University hospital
Alexandria
About this study
Official title: Predictors and Outcomes of Time to Hemostasis Post Trans-femoral Cardiac Catheterization: a Multicenter Cohort Study
This study aims to:
- Assess the incidence of hemostasis failure after manual compression of trans-femoral arterial sheath post percutaneous coronary intervention.
- Assess the predictors of time to hemostasis achieved by manual compression for trans-femoral arterial sheath post percutaneous coronary intervention.
- 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.
- 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hemostasis
The time frame (minutes) required for manual compression from the removal of sheath to achieve hemostasis
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: immediately before patient discharge from the hospital
Secondary outcomes (1)
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"
Measured: Immediately after femoral sheath removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start15 Aug 2022
- Primary completion5 May 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Gamal Ramadan Asal, Alexandria University
- Investigators
- Maha G Asal, Phd, Principal investigator, Alexandria UniversityEshrak S Hashem, Phd, Principal investigator, Alexandria UniversityWafaa H Awad, Phd, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501964
- Sponsor's protocol ID
- 1552022
- Status last verified
- Jun 2024
- First submitted
- 6 Aug 2022
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors and Outcomes of Time to Hemostasis Post Trans-femoral Cardiac Catheterization: a Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT05501964
- Acronym / sponsor ID
- 1552022
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to:
- Assess the incidence of hemostasis failure after manual compression of trans-femoral arterial sheath post percutaneous coronary intervention.
- Assess the predictors of time to hemostasis achieved by manual compression for trans-femoral arterial sheath post percutaneous coronary intervention.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients who planned for elective or primary percutaneous coronary intervention with femoral access, and
- Agreed to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
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.
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
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
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
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.
1 secondary outcome
Groin pain
Time frame: Immediately after femoral sheath removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make individual participant data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha G Asal, Phd principal investigator
Alexandria University
Eshrak S Hashem, Phd principal investigator
Alexandria University
Wafaa H Awad, Phd principal investigator
Alexandria University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Alexandria University at 5 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to hemostasis (time frame: 12 hours after percutaneous coronary intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.