Coagulopathy, Cardiac Surgery, Cardiopulmonary BypassNCT03475940
Coagulopathy in Cardiac Surgery
An observational study of Coagulopathy, Cardiac Surgery, Cardiopulmonary Bypass, run by Mahidol University at 2 sites in Thailand.
Trial summary
Coagulopathy in cardiac surgery; a quaternary-care academic center experience Objectives: Primary: To determine incidence of coagulopathy after cardiac surgery in Thai people To determine incidence of resternotomy for stop bleeding, morbidity and mortality Secondary: To identify risk factors which associated with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coagulopathy, Cardiac Surgery, Cardiopulmonary Bypass
- How many people
- 398 participants
- Where
- 2 sitesThailand
- Study dates
- 31 Dec 2017to 30 Jun 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Age ≥ 18 years Schedule to cardiac surgery under cardiopulmonary bypass
Who may be able to join
- Age ≥ 18 years
- Schedule to cardiac surgery under cardiopulmonary bypass
Who cannot join
- Schedule for aortic surgery or complex congenital cardiac surgery
- Using ECMO before surgery
- Incomplete anesthetic record
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
faculty of medicine Siriraj hospital
Bangkok, 10600
Faculty of medicine Siriraj hospital
Bangkok Noi, Bangkok, 10700
About this study
Official title: Coagulopathy in Cardiac Surgery; a Quaternary-care Academic Center Experience
Coagulopathy in cardiac surgery; a quaternary-care academic center experience
Objectives:
Primary:
To determine incidence of coagulopathy after cardiac surgery in Thai people To determine incidence of resternotomy for stop bleeding, morbidity and mortality
Secondary:
To identify risk factors which associated with non-red cell transfusion and coagulopathy
study decide: Retrospective chart review
Read the detailed description
Data to be collected:
Age*, gender* Body weight, height, body mass index* Underlying disease: DM, renal disease*, liver disease* Pre-op. Antiplatelet or anticoagulant* Pre-op coagulogram and platelet count* Emergency or elective surgery Resternotomy or not* Intraoperative blood component Intraoperative factor concentration Dose and timing of antifibrinolytic administration* CPB time* Postoperative body temperature*
*Possible risk factors for non-red cell transfusion
statistic: To assess the relationship between risk factors and non-red cell transfusion a univariate analysis was performed using an unpaired t-test and a Chi-square test.
For higher accuracy regarding the impact of single risk factors, a multiple logistic regression analysis was also performed.
- Medical subject headings
- Hemostatic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of coagulopathy after cardiac surgery in Thai people
coagulopathy and throbocytopenia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start31 Dec 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulopathy, Cardiac Surgery, Cardiopulmonary BypassStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaowanan Khamtuikrua, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475940
- Sponsor's protocol ID
- Si2018-2
- Status last verified
- Nov 2020
- First submitted
- 31 Dec 2017
- Last updated
- 17 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulopathy in Cardiac Surgery; a Quaternary-care Academic Center Experience
- ClinicalTrials.gov ID
- NCT03475940
- Acronym / sponsor ID
- Si2018-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 31 Dec 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 23 Mar 2018 (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.
Coagulopathy in cardiac surgery; a quaternary-care academic center experience
Objectives:
Primary:
To determine incidence of coagulopathy after cardiac surgery in Thai people To determine incidence of resternotomy for stop bleeding, morbidity and mortality
Secondary:
To identify risk factors which associated with non-red cell transfusion and coagulopathy
study decide: Retrospective chart review
Detailed description
Data to be collected:
Age*, gender* Body weight, height, body mass index* Underlying disease: DM, renal disease*, liver disease* Pre-op. Antiplatelet or anticoagulant* Pre-op coagulogram and platelet count* Emergency or elective surgery Resternotomy or not* Intraoperative blood component Intraoperative factor concentration Dose and timing of antifibrinolytic administration* CPB time* Postoperative body temperature*
*Possible risk factors for non-red cell transfusion
statistic: To assess the relationship between risk factors and non-red cell transfusion a univariate analysis was performed using an unpaired t-test and a Chi-square test.
For higher accuracy regarding the impact of single risk factors, a multiple logistic regression analysis was also performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Age ≥ 18 years Schedule to cardiac surgery under cardiopulmonary bypass
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Schedule to cardiac surgery under cardiopulmonary bypass
Key exclusion criteria (3 listed)
- Schedule for aortic surgery or complex congenital cardiac surgery
- Using ECMO before surgery
- Incomplete anesthetic record
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
incidence of coagulopathy after cardiac surgery in Thai people
Time frame: 1 year
coagulopathy and throbocytopenia
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 17 Nov 2020.
- Individual participant dataSharing planned: No
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Not yet recruitingObservational study
Flow-Based Platelet Function Assessment Using Total Thrombus-Formation Analysis System (T-TAS) and Early Bleeding After Cardiac Surgery With Cardiopulmonary Bypass (CPB)
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulopathy, Cardiac Surgery, Cardiopulmonary Bypass, run by Mahidol University at 2 sites in Thailand.
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 3 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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?
incidence of coagulopathy after cardiac surgery in Thai people (time frame: 1 year). 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 17 Nov 2020.