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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03475940
Other study ID # Si2018-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 31, 2017
Est. completion date June 30, 2020

Study information

Verified date November 2020
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 non-red cell transfusion and coagulopathy study decide: Retrospective chart review


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.


Recruitment information / eligibility

Status Completed
Enrollment 398
Est. completion date June 30, 2020
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years - Schedule to cardiac surgery under cardiopulmonary bypass Exclusion Criteria: - Schedule for aortic surgery or complex congenital cardiac surgery - Using ECMO before surgery - Incomplete anesthetic record

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand faculty of medicine Siriraj hospital Bangkok
Thailand Faculty of medicine Siriraj hospital Bangkok Noi Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of coagulopathy after cardiac surgery in Thai people coagulopathy and throbocytopenia 1 year