Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000043134
Ethics application status
Approved
Date submitted
17/12/2018
Date registered
14/01/2019
Date last updated
19/03/2019
Date data sharing statement initially provided
14/01/2019
Date results information initially provided
14/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of preoperative anemia incidence on postoperative mortality and morbidity in patients undergoing thoracic surgery
Scientific title
The effects of preoperative anemia incidence on postoperative mortality and morbidity in patients undergoing thoracic surgery
Secondary ID [1] 296706 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
preoperative anemia 310558 0
postoperative mortality 310559 0
postoperative morbidity 310886 0
Condition category
Condition code
Blood 309270 309270 0 0
Anaemia
Anaesthesiology 309683 309683 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We enrolled consecutive 104 patients between the age of 18 and 79 years. Patients’ demographic data, preoperative and postoperative complete blood count, rate of blood and blood product transfusions and complications were recorded during surgery. Additionally, other laboratory tests, surgery type, re-exploration, length of stay at hospital and intensive care unit were determined and recorded at first 48 hours after surgery. We classified patients into two groups: patients with anemia (n=29) and patients without anemia (n=75). According to the World Health Organization, anemia is defined as a hemoglobin level less than 12 g/dL in women and less than 13.0 g/dL in men.We took these reference levels into consideration for diagnosis of preoperative anemia in our study.
Intervention code [1] 313018 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308246 0
To determine the incidence of preoperative anemia in patients undergoing thoracic surgery. blood sample is taken from patient in operation room before surgery.
Timepoint [1] 308246 0
blood sample is taken from patient in operation room before surgery.
Secondary outcome [1] 354365 0
determine the mortality after surgery. the assessment of mortality: causes of death will be determined and recorded from hospital records.
Timepoint [1] 354365 0
48 hours post surgery

Eligibility
Key inclusion criteria
patients undergoing open thoracic surgery or thoracoscopy will be included in our center.
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
emergency surgery,
under 18 years of age,
known bleeding disorder,
renal insufficiency, hepatic failure or congestive heart failure

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Random sample
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
22/10/2018
Date of last data collection
Anticipated
Actual
24/10/2018
Sample size
Target
100
Accrual to date
Final
104
Recruitment outside Australia
Country [1] 21090 0
Turkey
State/province [1] 21090 0
istanbul

Funding & Sponsors
Funding source category [1] 301287 0
Hospital
Name [1] 301287 0
Marmara University Pendik Training Education Hospital
Country [1] 301287 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] 300938 0
Individual
Name [1] 300938 0
Meliha Orhon Ergun
Address [1] 300938 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] 300938 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302029 0
Marmara Universty Clinical Research Ethics Committee
Ethics committee address [1] 302029 0
Basibuyuk neighborhood, Basibuyuk street. no:9, 34854 Maltese/istanbul
Ethics committee country [1] 302029 0
Turkey
Date submitted for ethics approval [1] 302029 0
01/01/2018
Approval date [1] 302029 0
02/02/2018
Ethics approval number [1] 302029 0

Summary
Brief summary
The effects of preoperative anemia incidence on postoperative mortality and morbidity in patients undergoing thoracic surgery
Preoperative anemia; it is directly related to blood transfusions in the perioperative period, it increases the risk of transfusion-related side effects and complications. The aim of this prospective study was to determine the incidence of preoperative anemia in patients undergoing thoracic surgery and to determine the mortality and morbidity rates that may be related.
Preoperative anemia is a risk factor for transfusion of blood and blood products in patients undergoing thoracic surgery. There are three major risk factors for development of preoperative anemia in thoracic surgery: hospital-acquired anemia, iron deficiency anemia, and anemia of chronic disease. Our hypothesis in this study was that anemia may be related to increased perioperative complications, bleeding and transfusion rate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88894 0
Dr Ayten Saracoglu
Address 88894 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 88894 0
Turkey
Phone 88894 0
+905377810144
Fax 88894 0
Email 88894 0
[email protected]
Contact person for public queries
Name 88895 0
Dr Meliha Orhon Ergun
Address 88895 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 88895 0
Turkey
Phone 88895 0
+905413402001
Fax 88895 0
Email 88895 0
[email protected]
Contact person for scientific queries
Name 88896 0
Dr Meliha Orhon Ergun
Address 88896 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 88896 0
Turkey
Phone 88896 0
+905413402001
Fax 88896 0
Email 88896 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
No additional documents have been identified.