Coagulopathy in Cardiac Surgery

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

Study Overview

• Status: Completed
• Conditions: Coagulopathy, Cardiac Surgery, Cardiopulmonary Bypass

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 Type: Observational
• Enrollment (Actual): 398

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10600
    • Faculty of Medicine Siriraj Hospital
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Age ≥ 18 years Schedule to cardiac surgery under cardiopulmonary bypass

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of coagulopathy after cardiac surgery in Thai people	coagulopathy and throbocytopenia	1 year

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: December 31, 2017
• First Submitted That Met QC Criteria: March 17, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: Si2018-2

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