- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07600060
Frequency of Platelets Transfusion & Post-Operative Bleeding Risk in Patients on Clopidogrel Undergoing CABG
May 18, 2026 updated by: Khalid Siddiqui, Aga Khan University
Frequency of Platelets Transfusion and Post-Operative Bleeding Risk in Patients on Clopidogrel Undergoing Coronary Artery Bypass Grafting (CABG): A Retrospective Cohort
The goal of this retrospective cohort study Is to Primarily be platelet transfusion frequency and postoperative bleeding risk, analysis using descriptive and inferential statistics in all eligible patients admitted to the cardiac intensive care unit (CICU) for open-heart surgery were included of both gender, age group of 30-80 years. The main questions it aims to answer are:
- How was the frequency of platelet transfusion during the index admission evaluated?
- How was post-operative bleeding risk measured?
- What does 24-hour chest drain output indicate in this context?
- How was packed cell volume (PCV) transfusion used as an outcome measure?
Study Overview
Status
Completed
Conditions
Detailed Description
The Cardiac Intensive Care Unit (CICU) at a tertiary care facility in Karachi, Pakistan, served as the site of this retrospective cohort study.
Every procedure adhered to institutional policies, and safe data management and de-identification preserved confidentiality.
Consecutive sampling was employed due to the retrospective methodology, and the sample included all eligible CICU patients who had heart surgery during the study period.
The study included patients on dual antiplatelet treatment (DAPT: aspirin and/or clopidogrel) with the last dose within five days before to surgery, as well as adults between the ages of thirty and eighty undergoing heart surgery with cardiopulmonary bypass (CPB).
Study Type
Observational
Enrollment (Actual)
227
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 7480 0
- Aga Khan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All eligible patients admitted to the cardiac intensive care unit (CICU) for open-heart surgery were included.
Description
Inclusion Criteria:
- CICU patients who underwent cardiac surgery
- Adults aged 30-80 years undergoing cardiac surgery with cardiopulmonary bypass
- Patients who received dual antiplatelet therapy, last dose within 5 days before surgery
Exclusion Criteria:
- BMI > 40 kg/m²
- Repeat open-heart surgery (reoperation)
- Transferred open-chest procedures
- Active liver disease
- Chronic lung disease
- Dialysis dependence
- Intra-aortic balloon pump (IABP) in place pre- or post-operatively
- Major neurological deficit within the past 6 months
- Incomplete clinical records
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of platelet transfusion
Time Frame: From the day 1 of admission till discharge or 30 days of admission
|
The frequency of platelet transfusion during the hospital stay.
|
From the day 1 of admission till discharge or 30 days of admission
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to re-intubation
Time Frame: 30-60 seconds from laryngoscope insertion in the oral cavity tilldetection of end tidal carbon dioxide trace.
|
The number of times reintubation occurred, i.e. the endotracheal tube was reinserted.
|
30-60 seconds from laryngoscope insertion in the oral cavity tilldetection of end tidal carbon dioxide trace.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Khalid Siddiqui, MBBS-FCPS, Aga Khan University
- Principal Investigator: Khalid Siddiqui, Aga Khan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
May 31, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
March 25, 2026
First Submitted That Met QC Criteria
May 18, 2026
First Posted (Actual)
May 20, 2026
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2023-9576-27366
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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