Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001417178
Ethics application status
Approved
Date submitted
16/12/2018
Date registered
15/10/2019
Date last updated
15/10/2019
Date data sharing statement initially provided
15/10/2019
Date results information initially provided
15/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of antithrombotic drugs on thrombosis and bleeding risk in patients undergoing thoracic surgery
Scientific title
Effects of antithrombotic drugs on thrombosis and bleeding risk in patients undergoing thoracic surgery
Secondary ID [1] 296780 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
thrombosis 310675 0
bleeding 310887 0
Condition category
Condition code
Blood 309375 309375 0 0
Other blood disorders
Blood 309376 309376 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A total of 100 patients over 18 years of age who had undergone thoracic surgery were included in the study. Only if the patient has had more than one surgery, only the data of the first surgery will be included in the study.
Demographic data, cardiac reserves, preoperative and postoperative hemogram values, frequency of anticoagulant drug use, duration and type of drug, transfusion amount of blood and blood products, complications and mortality rates were recorded during surgery. In addition, other laboratory tests, type of surgery, frequency of re-exploration, duration of intensive care and hospital stay and causes of death were recorded first 48 hours after surgery.
Intervention code [1] 313084 0
Early Detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308334 0
upper extremity Deep Vein Thrombosis is followed and recorded after surgery by anesthesiologist.
Timepoint [1] 308334 0
48 hours after surgery
Secondary outcome [1] 354631 0
amount of hemorrhage checked from patients' blood sample by anesthesiologist.
Timepoint [1] 354631 0
48 hours after surgery

Eligibility
Key inclusion criteria
Cardiac patients over 18 years of age who will undergo open thoracic surgery or thoracoscopy and who use anticoagulants will be included in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with emergency surgery, patients under 18 years of age, patients with known bleeding disorder, patients with renal insufficiency, hepatic failure or congestive heart failure will be excluded from the study.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/02/2018
Date of last participant enrolment
Anticipated
Actual
2/11/2018
Date of last data collection
Anticipated
Actual
4/11/2018
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 21094 0
Turkey
State/province [1] 21094 0
istanbul

Funding & Sponsors
Funding source category [1] 301355 0
Hospital
Name [1] 301355 0
Marmara Universty and Pendik Training Education Hospital
Country [1] 301355 0
Turkey
Primary sponsor type
Individual
Name
Ayten Saracoglu
Address
Marmara Universty and Pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
Fevzi cakmak neighborhood, Mohsin yazicioglu street, no:10, 34899 pendik/istanbul
Country
Turkey
Secondary sponsor category [1] 301025 0
Individual
Name [1] 301025 0
Meliha Orhon Ergun
Address [1] 301025 0
Marmara Universty and Pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
Fevzi cakmak neighborhood, Mohsin yazicioglu street, no:10, 34899 pendik/istanbul
Country [1] 301025 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302098 0
Marmara Universty Clinical Research Ethics Committee
Ethics committee address [1] 302098 0
Basibuyuk neighborhood, Basibuyuk street. no:9, 34854 Maltese/istanbul
Ethics committee country [1] 302098 0
Turkey
Date submitted for ethics approval [1] 302098 0
02/01/2018
Approval date [1] 302098 0
02/02/2018
Ethics approval number [1] 302098 0

Summary
Brief summary
Drug withdrawal in the preoperative period may give rise to the risks, such as rebound phenomenon or thrombosis. Our aim is to determine the incidence of thrombotic complications that may be associated with discontinuation of preoperative anticoagulants in patients undergoing thoracic surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89102 0
Dr Ayten Saracoglu
Address 89102 0
Marmara Universty and Pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
Fevzi cakmak neighborhood, Mohsin yazicioglu street, no:10, 34899 pendik/istanbul
Country 89102 0
Turkey
Phone 89102 0
+905377810144
Fax 89102 0
Email 89102 0
[email protected]
Contact person for public queries
Name 89103 0
Dr Meliha Orhon Ergun
Address 89103 0
Marmara Universty and Pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
Fevzi cakmak neighborhood, Mohsin yazicioglu street, no:10, 34899 pendik/istanbul
Country 89103 0
Turkey
Phone 89103 0
+905413402001
Fax 89103 0
Email 89103 0
[email protected]
Contact person for scientific queries
Name 89104 0
Dr Meliha Orhon Ergun
Address 89104 0
Marmara Universty and Pendik Training Education Hospital Clinic of Anesthesiology and Reanimation
Fevzi cakmak neighborhood, Mohsin yazicioglu street, no:10, 34899 pendik/istanbul
Country 89104 0
Turkey
Phone 89104 0
+905413402001
Fax 89104 0
Email 89104 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of Acetyl Salicylic Acid on the Risk of Thrombosis in Patients Undergoing Thoracic Surgery.2022https://dx.doi.org/10.14744/GKDAD.2022.70894
N.B. These documents automatically identified may not have been verified by the study sponsor.