AzTrials
AzTrials

SurgeryCeKATUNCT03468738

Investigation of the Transfusion Practices in Surgical Patients in Turkey

An observational study of Surgery and Blood Loss, Surgical, run by Diskapi Teaching and Research Hospital at 61 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this study is to describe the transfusion practices in patients undergoing major surgery in Turkey. The transfusion rates of red blood cells (RBC), fresh frozen plasma (FFP) and platelets; the transfusion predictors and transfusion related patient outcomes are investigated. Read more about this study

Who is it for?
Any age
Conditions the study is for
Surgery, Blood Loss, Surgical, Blood Loss Anemia
What is being tested?
Blood transfusion
How many people
6,481 participants
Where
61 sitesTurkey (Türkiye)
Study dates
2 Apr 2018to 1 Feb 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients undergoing major elective surgery in General surgery Orthopedics Urology Transplantation surgery Neurosurgery Gynecology and obstetrics Cardiovascular surgery

Who may be able to join

  • Patients undergoing major elective surgery

Who cannot join

  • Trauma patients, emergency surgery

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

Turkey (Türkiye)61 sites

  • Acibadem University Mehmet Ali Aydinlar Atakent Hospital

    Ankara

  • Ankara University Cebeci Medical Center

    Ankara

  • Ankara University Ibni Sina Hospital

    Ankara

  • Başkent University Ankara Hospital

    Ankara

  • Gazi University Medical Faculty

    Ankara

  • Hacettepe University Medical Faculty

    Ankara

  • Private Cankaya Hospital

    Ankara

  • Ufuk University Medical Faculty Dr. Ridvan Ege Training and Research Hospital

    Ankara

  • University of Health sciences Ankara Child Health and Diseases Hematology Oncology Training and research Hospital

    Ankara

  • University of Health Sciences Ankara Numune Training and Research Hospital

    Ankara

  • University of Health Sciences Ankara Training and Research Hospital

    Ankara

  • University of Health Sciences Diskapi Yildirim Beyazit Trainig Research Hospital

    Ankara

  • University of Health Sciences Dr Abdurrahman Yurtaslanı Ankara Oncology Training and Research Hospital

    Ankara

  • University of Health Sciences Kecioren Training and Research Hospital

    Ankara

  • University of Health Sciences Turkiye Yuksek Ihtisas Training and Research Hospital

    Ankara

  • University of Health Sciences Yenimahalle Training and Research Hospital

    Ankara

  • University of Health Sciences Zubeyde Hanim Gynecology and Maternity Training and Research Hospital

    Ankara

  • University of Technology and Economics Medical Faculty

    Ankara

  • Akdeniz University Medical Faculty

    Antalya

  • University of Health Sciences Antalya Training and Research Hospital

    Antalya

  • Balikesir University Training and Research Hospital

    Balıkesir

  • Uludağ University Medical Faculty

    Bursa

  • University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

    Bursa

  • Hitit University Corum Erol Olcok Training and Research Hospital

    Çorum

  • Trakya University Medical Faculty

    Edirne

  • Fırat University Medical Faculty

    Elâzığ

  • Erzincan University Mengucek Gazi Training and Research Hospital

    Erzincan

  • Eskisehir Osmangazi University Medical Faculty

    Eskişehir

  • Suleyman Demirel University Medical Faculty

    Isparta

  • Acibadem University Altunizade Hospital

    Istanbul

  • Istanbul Medeniyet University Goztepe Training and Research Hospital

    Istanbul

  • Istanbul University Medical Faculty

    Istanbul

  • Marmara University Pendik Training and Research Hospital

    Istanbul

  • University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital

    Istanbul

  • University of Health Sciences Haydarpasa Numne Training and Research Hospital

    Istanbul

  • University of Health Sciences Istanbul Training and Research Hospital

    Istanbul

  • University of Health Sciences Kanuni Sultan Suleyman Training and Research Hospital

    Istanbul

  • University of Health Sciences Okmeydanı Training and Research Hospital

    Istanbul

  • University of Health Sciences Umraniye Training and Research Hospital

    Istanbul

  • Dokuz Eylul University Medical Faculty

    Izmir

  • University of Health Sciences Bozyaka Training Research Hospital

    Izmir

  • University of Health Sciences İzmir Tepecik Training and Research Hospital

    Izmir

  • Sutcu Imam University Medical Faculty

    Kahramanmaraş

  • Erciyes University Medical Faculty

    Kayseri

  • University of Health Sciences Kayseri Training and Research Hospital

    Kayseri

  • Anadolu Health Center Hospital

    Kocaeli

  • University of Health Sciences Derince Training and Research Hospital

    Kocaeli

  • Necmettin Erbakan University Meram Medical Faculty Center for Health and Research

    Konya

  • Selcuk University Medical Faculty

    Konya

  • University of Health Sciences Konya Training and Research Hospital

    Konya

  • Inonu University Liver Transplantation Institute

    Malatya

  • Manisa Celal Bayar University Medical Faculty Hafsa Sultan Hospital

    Manisa

  • Mersin University Medical Faculty

    Mersin

  • Ordu University Medical Faculty

    Ordu

  • Osmaniye State Hospital

    Osmaniye

  • Ondokuz Mayıs University Medical Faculty

    Samsun

  • Namık Kemal University Medical Faculty

    Tekirdağ

  • Karadeniz Technical University Medical Faculty Farabi Hospital

    Trabzon

  • Tunceli State Hospital

    Tunceli

  • Van Yuzuncuyıl University Medical Faculty Dursun Odabası Center

    Van

  • Bulent Ecevit University Medical Faculty Center for Health and Research

    Zonguldak

Other trials in Turkey (Türkiye)

About this study

The aim of this study is to describe the transfusion practices in patients undergoing major surgery in Turkey. The transfusion rates of red blood cells (RBC), fresh frozen plasma (FFP) and platelets; the transfusion predictors and transfusion related patient outcomes are investigated.

Read the detailed description

Patient Blood Management (PBM) is an evidence based multidisciplinary approach for the care of patients who may need blood transfusion. The aim of PBM is achieving better patient outcomes by focusing on the patients' own blood as a source.

To date PBM is considered "good transfusion practice" and is being implemented in a growing number of countries. The Turkish Society of Anesthesiologists PBM Task Force is working on this subject since 4 years and decided to conduct a study. Before starting a PBM program, the transfusion practices of clinicians working at diverse surgical fields; differences between current transfusion practices and PBM strategies; the areas for improvement and the obstacles that could prevent change could be identified with this study. Data collection will also serve to identify the current situation as a reference and to control the achievement of the PBM's aim: improving clinical outcomes. These data will be refered as The Turkish National Perioperative Transfusion Study (TULIP TS) data.

The aim of this study is to describe the transfusion practices in patients undergoing major surgery in Turkey.

The study evaluates i. The perioperative transfusion rates of RBCs, FFP and platelets. ii. With which reasons the anesthesiologists decide to transfuse a patient (co morbidities of the patients, physiologic transfusion triggers, hemoglobin trigger, uncontrolled bleeding, on request from surgeon etc.).

iii. The relation of transfusion and the patients co-morbidity index, the P POSSUM score and SORT score; anesthesia methods; monitorisation methods (hemodynamic, coagulation); amount of bleeding; type of surgery; type of hospital.

iv. The relation of transfusion and patient outcomes (unanticipated ICU admission, prolonged ICU stay, acute renal failure, thromboembolic events, ischemic events, pulmonary complications, cardiac advers events, infections, acute respiratory distress, infection, all-cause mortality).

Being tested
Blood transfusion
Medical subject headings
Blood Loss, Surgical, Anemia, Hemostatic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood transfusionOther

    Transfusion of blood products in the perioperative period in patients undergoing major surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preoperative amount of blood products transfused

    Preoperative amount of blood products: RBCs,FFP and platelets transfused

    Measured: Before surgery at day 0

  2. Intraoperative amount of blood products transfused

    Intraoperative amount of blood products: RBC's,FFP and platelets transfused

    Measured: During surgery at day 0

  3. Postoperative amount of blood products transfused

    Postoperative amount of blood products: RBCs,FFP and platelets transfused

    Measured: 24 hours after surgery

Secondary outcomes (17)

  1. Preoperative transfusion indications

    The reasons to decide to transfuse (factors determining transfusion) blood products

    Measured: Before surgery at day 0

  2. Intraoperative transfusion indications

    The reasons to decide to transfuse (factors determining transfusion) blood products

    Measured: During surgery at day 1

  3. Postoperative transfusion indications

    The reasons to decide to transfuse (factors determining transfusion) blood products

    Measured: 24 hours after surgery

  4. Unanticipated ICU admission

    Whether the patient had an unanticipated ICU admission

    Measured: After surgery at day 1

  5. Prolonged length of stay in ICU

    Whether the patient had a prolonged length of stay in ICU

    Measured: After surgery at day 2

  6. Acute renal failure

    Whether the patient had acute renal failure

    Measured: After surgery at day 2

  7. Thromboembolic event

    Whether the patient had a thromboembolic event concerning lungs (pulmonary embolism), brain (stroke), gastrointestinal tract, kidneys, or extremities etc.

    Measured: After surgery at day 2

  8. Ischemic event

    Whether the patient had an ischemic event concerning heart, nervous system,limb, gastrointestinal tract etc.

    Measured: After surgery at day 2

  9. Infection

    Whether the patient had infection: wound, pneumonia, urinary, sepsis etc.

    Measured: After surgery at day 2

  10. Acute respiratory distress

    Whether the patient had acute respiratory distress

    Measured: After surgery at day 2

  11. Mortality

    Whether the patient died: all cause mortality

    Measured: after surgery at day 30

  12. Preoperative anemia

    Whether the patient had anemia (Hemoglobin male < 13 female < 12 g/dL)

    Measured: Before surgery at day 0

  13. Preoperative coagulopathy

    Whether the patient had coagulopathy due to disease or drugs

    Measured: Before surgery at day 0

  14. Pretransfusion hemoglobin values

    The hemoglobin concentration before transfusion

    Measured: Before surgery at day 0

  15. Pretransfusion hemoglobin values

    The hemoglobin concentration before transfusion

    Measured: During surgery at day 1

  16. Pretransfusion hemoglobin values

    The hemoglobin concentration before transfusion

    Measured: After surgery at day 2

  17. Advers cardiac events

    Whether the patient had an advers cardiac event: myocardial infaction; non fatal cardiac arest; arrhytmia; cardiogenic pulmonary edema etc

    Measured: After surgery at day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2018
  2. Study start2 Apr 2018
  3. Primary completion1 Feb 2019
  4. Study completion1 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
6,481 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03468738
Sponsor's protocol ID
Dilek Yazıcıoglu Unal
Acronym
CeKATU
Status last verified
Apr 2018
First submitted
11 Mar 2018
Last updated
25 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kotze A, Carter LA, Scally AJ. Effect of a patient blood management programme on preoperative anaemia, transfusion rate, and outcome after primary hip or knee arthroplasty: a quality improvement cycle. Br J Anaesth. 2012 Jun;108(6):943-52. doi: 10.1093/bja/aes135.

    PubMed 22593128

  • Meier J, Filipescu D, Kozek-Langenecker S, Llau Pitarch J, Mallett S, Martus P, Matot I; ETPOS collaborators. Intraoperative transfusion practices in Europe. Br J Anaesth. 2016 Feb;116(2):255-61. doi: 10.1093/bja/aev456.

    PubMed 26787795

  • Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, Culliford L, Angelini GD. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007 Nov 27;116(22):2544-52. doi: 10.1161/CIRCULATIONAHA.107.698977. Epub 2007 Nov 12.

    PubMed 17998460

  • Hsieh FY, Bloch DA, Larsen MD. A simple method of sample size calculation for linear and logistic regression. Stat Med. 1998 Jul 30;17(14):1623-34. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-s.

    PubMed 9699234

  • Kalil AC, Mattei J, Florescu DF, Sun J, Kalil RS. Recommendations for the assessment and reporting of multivariable logistic regression in transplantation literature. Am J Transplant. 2010 Jul;10(7):1686-94. doi: 10.1111/j.1600-6143.2010.03141.x.

    PubMed 20642690

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery and Blood Loss, Surgical, run by Diskapi Teaching and Research Hospital at 61 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preoperative amount of blood products transfused (time frame: Before surgery at day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03468738, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in