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CompletedNCT03468738CeKATUUpdated Apr 25, 2019

Investigation of the Transfusion Practices in Surgical Patients in Turkey

An observational study in Surgery, Blood Loss, Surgical and Blood Loss Anemia, sponsored by Diskapi Teaching and Research Hospital. Completed at 61 sites in Turkey. Per ClinicalTrials.gov, last updated 2019-04-25.

Sponsored by Diskapi Teaching and Research Hospital · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
6,481
Sex
All
01

Study 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 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).

02

Conditions studied

  • Surgery
  • Blood Loss, Surgical
  • Blood Loss Anemia
  • Blood Transfusion
  • Anemia
  • Coagulation Disorder
03

In context

Blood Loss, Surgical

213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.

This study's enrollment of 6,481 is above the median of 154 across 43 observational studies indexed under Blood Loss, Surgical.

Browse Blood Loss, Surgical studies →

Lead sponsor

Diskapi Teaching and Research Hospital is the lead sponsor of 106 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients undergoing major elective surgery

Exclusion criteria

Exclusion Criteria:

Trauma patients, emergency surgery

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
6,481 participants (actual)
Patient registry
No

Interventions

  • OtherBlood transfusion

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

06

What researchers measure

Primary outcomes

  1. Preoperative amount of blood products transfused

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

    Time frame: Before surgery at day 0

  2. Intraoperative amount of blood products transfused

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

    Time frame: During surgery at day 0

  3. Postoperative amount of blood products transfused

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

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Preoperative transfusion indications

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

    Time frame: Before surgery at day 0

  2. Intraoperative transfusion indications

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

    Time frame: During surgery at day 1

  3. Postoperative transfusion indications

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

    Time frame: 24 hours after surgery

  4. Unanticipated ICU admission

    Whether the patient had an unanticipated ICU admission

    Time frame: After surgery at day 1

  5. Prolonged length of stay in ICU

    Whether the patient had a prolonged length of stay in ICU

    Time frame: After surgery at day 2

  6. Acute renal failure

    Whether the patient had acute renal failure

    Time frame: 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.

    Time frame: After surgery at day 2

  8. Ischemic event

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

    Time frame: After surgery at day 2

  9. Infection

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

    Time frame: After surgery at day 2

  10. Acute respiratory distress

    Whether the patient had acute respiratory distress

    Time frame: After surgery at day 2

  11. Mortality

    Whether the patient died: all cause mortality

    Time frame: after surgery at day 30

  12. Preoperative anemia

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

    Time frame: Before surgery at day 0

  13. Preoperative coagulopathy

    Whether the patient had coagulopathy due to disease or drugs

    Time frame: Before surgery at day 0

  14. Pretransfusion hemoglobin values

    The hemoglobin concentration before transfusion

    Time frame: Before surgery at day 0

  15. Pretransfusion hemoglobin values

    The hemoglobin concentration before transfusion

    Time frame: During surgery at day 1

  16. Pretransfusion hemoglobin values

    The hemoglobin concentration before transfusion

    Time frame: 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

    Time frame: After surgery at day 30

07

Study locations

61 sites
  • Acibadem University Mehmet Ali Aydinlar Atakent Hospital
    Ankara, Turkey
  • Ankara University Cebeci Medical Center
    Ankara, Turkey
  • Ankara University Ibni Sina Hospital
    Ankara, Turkey
  • Başkent University Ankara Hospital
    Ankara, Turkey
  • Gazi University Medical Faculty
    Ankara, Turkey
  • Hacettepe University Medical Faculty
    Ankara, Turkey
  • Private Cankaya Hospital
    Ankara, Turkey
  • Ufuk University Medical Faculty Dr. Ridvan Ege Training and Research Hospital
    Ankara, Turkey
  • University of Health sciences Ankara Child Health and Diseases Hematology Oncology Training and research Hospital
    Ankara, Turkey
  • University of Health Sciences Ankara Numune Training and Research Hospital
    Ankara, Turkey
  • University of Health Sciences Ankara Training and Research Hospital
    Ankara, Turkey
  • University of Health Sciences Diskapi Yildirim Beyazit Trainig Research Hospital
    Ankara, Turkey
  • University of Health Sciences Dr Abdurrahman Yurtaslanı Ankara Oncology Training and Research Hospital
    Ankara, Turkey
  • University of Health Sciences Kecioren Training and Research Hospital
    Ankara, Turkey
  • University of Health Sciences Turkiye Yuksek Ihtisas Training and Research Hospital
    Ankara, Turkey
  • University of Health Sciences Yenimahalle Training and Research Hospital
    Ankara, Turkey
  • University of Health Sciences Zubeyde Hanim Gynecology and Maternity Training and Research Hospital
    Ankara, Turkey
  • University of Technology and Economics Medical Faculty
    Ankara, Turkey
  • Akdeniz University Medical Faculty
    Antalya, Turkey
  • University of Health Sciences Antalya Training and Research Hospital
    Antalya, Turkey
  • Balikesir University Training and Research Hospital
    Balıkesir, Turkey
  • Uludağ University Medical Faculty
    Bursa, Turkey
  • University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
    Bursa, Turkey
  • Trakya University Medical Faculty
    Edirne, Turkey
  • Fırat University Medical Faculty
    Elazığ, Turkey
  • Erzincan University Mengucek Gazi Training and Research Hospital
    Erzincan, Turkey
  • Eskisehir Osmangazi University Medical Faculty
    Eskişehir, Turkey
  • Suleyman Demirel University Medical Faculty
    Isparta, Turkey
  • Acibadem University Altunizade Hospital
    Istanbul, Turkey
  • Istanbul Medeniyet University Goztepe Training and Research Hospital
    İstanbul, Turkey
  • Istanbul University Medical Faculty
    Istanbul, Turkey
  • Marmara University Pendik Training and Research Hospital
    Istanbul, Turkey
  • University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital
    Istanbul, Turkey
  • University of Health Sciences Haydarpasa Numne Training and Research Hospital
    Istanbul, Turkey
  • University of Health Sciences Istanbul Training and Research Hospital
    Istanbul, Turkey
  • University of Health Sciences Kanuni Sultan Suleyman Training and Research Hospital
    Istanbul, Turkey
  • University of Health Sciences Okmeydanı Training and Research Hospital
    Istanbul, Turkey
  • University of Health Sciences Umraniye Training and Research Hospital
    Istanbul, Turkey
  • Dokuz Eylul University Medical Faculty
    İzmir, Turkey
  • University of Health Sciences Bozyaka Training Research Hospital
    İzmir, Turkey
  • University of Health Sciences İzmir Tepecik Training and Research Hospital
    İzmir, Turkey
  • Sutcu Imam University Medical Faculty
    Kahramanmaraş, Turkey
  • Erciyes University Medical Faculty
    Kayseri, Turkey
  • University of Health Sciences Kayseri Training and Research Hospital
    Kayseri, Turkey
  • Anadolu Health Center Hospital
    Kocaeli, Turkey
  • University of Health Sciences Derince Training and Research Hospital
    Kocaeli, Turkey
  • Necmettin Erbakan University Meram Medical Faculty Center for Health and Research
    Konya, Turkey
  • Selcuk University Medical Faculty
    Konya, Turkey
  • University of Health Sciences Konya Training and Research Hospital
    Konya, Turkey
  • Inonu University Liver Transplantation Institute
    Malatya, Turkey
  • Manisa Celal Bayar University Medical Faculty Hafsa Sultan Hospital
    Manisa, Turkey
  • Mersin University Medical Faculty
    Mersin, Turkey
  • Ordu University Medical Faculty
    Ordu, Turkey
  • Osmaniye State Hospital
    Osmaniye, Turkey
  • Ondokuz Mayıs University Medical Faculty
    Samsun, Turkey
  • Namık Kemal University Medical Faculty
    Tekirdağ, Turkey
  • Karadeniz Technical University Medical Faculty Farabi Hospital
    Trabzon, Turkey
  • Tunceli State Hospital
    Tunceli, Turkey
  • Van Yuzuncuyıl University Medical Faculty Dursun Odabası Center
    Van, Turkey
  • Bulent Ecevit University Medical Faculty Center for Health and Research
    Zonguldak, Turkey
  • Hitit University Corum Erol Olcok Training and Research Hospital
    Çorum, Turkey
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Feb 2019, 9 months.

Of 23 observational studies under Blood Loss, Surgical, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 60. This study's 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2018
First posted
Mar 19, 2018
StartActual
Apr 2, 2018
Primary completionActual
Feb 1, 2019
CompletionActual
Feb 1, 2019
Last update
Apr 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03468738
Collaborators
Turkish Society of Anesthesiology and Reanimation
Responsible party
DILEK YAZICIOGLU (Associate Professor, Diskapi Teaching and Research Hospital) — Principal investigator
First posted
Mar 19, 2018
Start date
Apr 2, 2018
Primary completion
Feb 1, 2019
Completion
Feb 1, 2019
Last update
Apr 25, 2019

Study contacts

Dilek Unal, Assoc Prof
principal investigator · Netherlands: Ministry of Health, Welfare and Sports

Oversight

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

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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