CClinicalTrials.gg
CompletedNCT03475940Updated Nov 17, 2020

Coagulopathy in Cardiac Surgery

An observational study in Coagulopathy, Cardiac Surgery, Cardiopulmonary Bypass, sponsored by Mahidol University. Completed at 2 sites in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-17.

Sponsored by Mahidol University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
398
Ages
18 Years and older
Sex
All
01

Study 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

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.

02

Conditions studied

  • Coagulopathy, Cardiac Surgery, Cardiopulmonary Bypass
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Age ≥ 18 years Schedule to cardiac surgery under cardiopulmonary bypass

Inclusion criteria

  • Age ≥ 18 years
  • Schedule to cardiac surgery under cardiopulmonary bypass

Exclusion criteria

Exclusion Criteria:

  • Schedule for aortic surgery or complex congenital cardiac surgery
  • Using ECMO before surgery
  • Incomplete anesthetic record
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
398 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. incidence of coagulopathy after cardiac surgery in Thai people

    coagulopathy and throbocytopenia

    Time frame: 1 year

06

Study locations

2 sites
  • Faculty of medicine Siriraj hospital
    Bangkok Noi, Bangkok 10700, Thailand
  • faculty of medicine Siriraj hospital
    Bangkok, 10600, Thailand
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03475940
Lead sponsor
Mahidol University
Responsible party
Chaowanan Khamtuikrua (lecturer, Mahidol University) — Principal investigator
First posted
Mar 23, 2018
Start date
Dec 31, 2017
Primary completion
Jun 30, 2019
Completion
Jun 30, 2020
Last update
Nov 17, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion