CeKATU: Investigation of the Transfusion Practices in Surgical Patients in Turkey

Sponsor
Diskapi Teaching and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03468738
Collaborator
Turkish Society of Anesthesiology and Reanimation (Other)
6,481
61
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood transfusion

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.).

  1. 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.

  2. 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).

Study Design

Study Type:
Observational
Actual Enrollment :
6481 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Investigation of the Transfusion Practices in Surgical Patients in Turkey
Actual Study Start Date :
Apr 2, 2018
Actual Primary Completion Date :
Feb 1, 2019
Actual Study Completion Date :
Feb 1, 2019

Outcome Measures

Primary Outcome Measures

  1. Preoperative amount of blood products transfused [Before surgery at day 0]

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

  2. Intraoperative amount of blood products transfused [During surgery at day 0]

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

  3. Postoperative amount of blood products transfused [24 hours after surgery]

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

Secondary Outcome Measures

  1. Preoperative transfusion indications [Before surgery at day 0]

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

  2. Intraoperative transfusion indications [During surgery at day 1]

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

  3. Postoperative transfusion indications [24 hours after surgery]

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

  4. Unanticipated ICU admission [After surgery at day 1]

    Whether the patient had an unanticipated ICU admission

  5. Prolonged length of stay in ICU [After surgery at day 2]

    Whether the patient had a prolonged length of stay in ICU

  6. Acute renal failure [After surgery at day 2]

    Whether the patient had acute renal failure

  7. Thromboembolic event [After surgery at day 2]

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

  8. Ischemic event [After surgery at day 2]

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

  9. Infection [After surgery at day 2]

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

  10. Acute respiratory distress [After surgery at day 2]

    Whether the patient had acute respiratory distress

  11. Mortality [after surgery at day 30]

    Whether the patient died: all cause mortality

  12. Preoperative anemia [Before surgery at day 0]

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

  13. Preoperative coagulopathy [Before surgery at day 0]

    Whether the patient had coagulopathy due to disease or drugs

  14. Pretransfusion hemoglobin values [Before surgery at day 0]

    The hemoglobin concentration before transfusion

  15. Pretransfusion hemoglobin values [During surgery at day 1]

    The hemoglobin concentration before transfusion

  16. Pretransfusion hemoglobin values [After surgery at day 2]

    The hemoglobin concentration before transfusion

  17. Advers cardiac events [After surgery at day 30]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Patients undergoing major elective surgery

Exclusion Criteria:

Trauma patients, emergency surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Acibadem University Mehmet Ali Aydinlar Atakent Hospital Ankara Turkey
2 Ankara University Cebeci Medical Center Ankara Turkey
3 Ankara University Ibni Sina Hospital Ankara Turkey
4 Başkent University Ankara Hospital Ankara Turkey
5 Gazi University Medical Faculty Ankara Turkey
6 Hacettepe University Medical Faculty Ankara Turkey
7 Private Cankaya Hospital Ankara Turkey
8 Ufuk University Medical Faculty Dr. Ridvan Ege Training and Research Hospital Ankara Turkey
9 University of Health sciences Ankara Child Health and Diseases Hematology Oncology Training and research Hospital Ankara Turkey
10 University of Health Sciences Ankara Numune Training and Research Hospital Ankara Turkey
11 University of Health Sciences Ankara Training and Research Hospital Ankara Turkey
12 University of Health Sciences Diskapi Yildirim Beyazit Trainig Research Hospital Ankara Turkey
13 University of Health Sciences Dr Abdurrahman Yurtaslanı Ankara Oncology Training and Research Hospital Ankara Turkey
14 University of Health Sciences Kecioren Training and Research Hospital Ankara Turkey
15 University of Health Sciences Turkiye Yuksek Ihtisas Training and Research Hospital Ankara Turkey
16 University of Health Sciences Yenimahalle Training and Research Hospital Ankara Turkey
17 University of Health Sciences Zubeyde Hanim Gynecology and Maternity Training and Research Hospital Ankara Turkey
18 University of Technology and Economics Medical Faculty Ankara Turkey
19 Akdeniz University Medical Faculty Antalya Turkey
20 University of Health Sciences Antalya Training and Research Hospital Antalya Turkey
21 Balikesir University Training and Research Hospital Balıkesir Turkey
22 Uludağ University Medical Faculty Bursa Turkey
23 University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital Bursa Turkey
24 Trakya University Medical Faculty Edirne Turkey
25 Fırat University Medical Faculty Elazığ Turkey
26 Erzincan University Mengucek Gazi Training and Research Hospital Erzincan Turkey
27 Eskisehir Osmangazi University Medical Faculty Eskişehir Turkey
28 Suleyman Demirel University Medical Faculty Isparta Turkey
29 Acibadem University Altunizade Hospital Istanbul Turkey
30 Istanbul Medeniyet University Goztepe Training and Research Hospital İstanbul Turkey
31 Istanbul University Medical Faculty Istanbul Turkey
32 Marmara University Pendik Training and Research Hospital Istanbul Turkey
33 University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital Istanbul Turkey
34 University of Health Sciences Haydarpasa Numne Training and Research Hospital Istanbul Turkey
35 University of Health Sciences Istanbul Training and Research Hospital Istanbul Turkey
36 University of Health Sciences Kanuni Sultan Suleyman Training and Research Hospital Istanbul Turkey
37 University of Health Sciences Okmeydanı Training and Research Hospital Istanbul Turkey
38 University of Health Sciences Umraniye Training and Research Hospital Istanbul Turkey
39 Dokuz Eylul University Medical Faculty İzmir Turkey
40 University of Health Sciences Bozyaka Training Research Hospital İzmir Turkey
41 University of Health Sciences İzmir Tepecik Training and Research Hospital İzmir Turkey
42 Sutcu Imam University Medical Faculty Kahramanmaraş Turkey
43 Erciyes University Medical Faculty Kayseri Turkey
44 University of Health Sciences Kayseri Training and Research Hospital Kayseri Turkey
45 Anadolu Health Center Hospital Kocaeli Turkey
46 University of Health Sciences Derince Training and Research Hospital Kocaeli Turkey
47 Necmettin Erbakan University Meram Medical Faculty Center for Health and Research Konya Turkey
48 Selcuk University Medical Faculty Konya Turkey
49 University of Health Sciences Konya Training and Research Hospital Konya Turkey
50 Inonu University Liver Transplantation Institute Malatya Turkey
51 Manisa Celal Bayar University Medical Faculty Hafsa Sultan Hospital Manisa Turkey
52 Mersin University Medical Faculty Mersin Turkey
53 Ordu University Medical Faculty Ordu Turkey
54 Osmaniye State Hospital Osmaniye Turkey
55 Ondokuz Mayıs University Medical Faculty Samsun Turkey
56 Namık Kemal University Medical Faculty Tekirdağ Turkey
57 Karadeniz Technical University Medical Faculty Farabi Hospital Trabzon Turkey
58 Tunceli State Hospital Tunceli Turkey
59 Van Yuzuncuyıl University Medical Faculty Dursun Odabası Center Van Turkey
60 Bulent Ecevit University Medical Faculty Center for Health and Research Zonguldak Turkey
61 Hitit University Corum Erol Olcok Training and Research Hospital Çorum Turkey

Sponsors and Collaborators

  • Diskapi Teaching and Research Hospital
  • Turkish Society of Anesthesiology and Reanimation

Investigators

  • Principal Investigator: Dilek Unal, Assoc Prof, Netherlands: Ministry of Health, Welfare and Sports

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
DILEK YAZICIOGLU, Associate Professor, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT03468738
Other Study ID Numbers:
  • Dilek Yazıcıoglu Unal
First Posted:
Mar 19, 2018
Last Update Posted:
Apr 25, 2019
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2019