Blood TransfusionNCT03930355
Perioperative Transfusion Related Outcome
An observational study of Blood Transfusion, run by Diskapi Teaching and Research Hospital at 60 sites in Turkey (Türkiye).
Trial summary
A secondary analysis of the Turkish National Perioperative Transfusion Study (TULIP TS) database will be performed. Read more about this study
- Who is it for?
- Ages 1 day to 100 years
- Conditions the study is for
- Blood Transfusion
- What is being tested?
- Blood transfusion
- How many people
- 6,121 participants
- Where
- 60 sitesTurkey (Türkiye)
- Study dates
- 1 May 2019to 30 Dec 2020
- 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 1 day to 100 years
- 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
60 sites in 1 country.
60 sites in 1 country
Turkey (Türkiye)60 sites
Diskapi Yildirim Beyazit Teaching and Research Hospital
Ankara, 06610
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 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
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
About this study
Official title: Effect of Perioperative Transfusion on Early and Late Outcome After Major Elective Surgery
A secondary analysis of the Turkish National Perioperative Transfusion Study (TULIP TS) database will be performed.
Read the detailed description
The Turkish National Perioperative Transfusion Study (TULIP TS) was conducted by The Turkish Society of Anesthesiologists' Multicentre Clinical Trials Network.
TULIP TS included 6481 patients undergoing major elective surgery, from 61 study sites across the country.
Transfusion practices of clinicians working at diverse surgical fields; differences between current transfusion practices and patient blood management strategies; the areas for improvement and the obstacles that could prevent change were evaluated and identified.
Data relevant to perioperative transfusion rates of red blood cells, fresh frozen plasma and platelets, the indications for transfusion and postoperative adverse outcomes including 1 month all cause mortality was obtained.
The TULIP TS group aims to collect further data concerning 1 year all cause mortality of the same patient population and to evaluate adverse outcomes in transfused and non transfused patients.
- Conditions
- Blood Transfusion
- Being tested
- Blood transfusion, Control
- Keywords
- Surgery, Perioperative, Transfusion, Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionOther
Patients who received blood transfusion in the perioperative period
ControlOther
Patients who did not receive blood transfusion in the perioperative period
| Study group | Role | What they receive |
|---|---|---|
| Transfused | Patients who received blood transfusion in the perioperative period Receives: Other: Blood transfusion | |
| Non transfused | Patients who did not receive blood transfusion in the perioperative period Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year all cause mortality
Number of participants died: all cause mortality
Measured: postoperative 366th day
Acute kidney injury
Number of participants with acute kidney injury
Measured: postoperative 30th day
Acute respiratory failure
Number of participants with acute respiratory failure
Measured: postoperative 30th day
Thromboembolic event
Number of participants with a thromboembolic event
Measured: postoperative 30th day
Ischemic event
Number of participants with an ischemic event
Measured: postoperative 30th day
Infection
Number of participants with infection
Measured: postoperative 30th day
Myocardial infarction
Number of participants with myocardial infarction
Measured: postoperative 30th day
Adverse cardiac event
Number of participants with an adverse cardiac event
Measured: postoperative 30th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 May 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood TransfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 6,121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
- Investigators
- Dilek Ünal, Principal investigator, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930355
- Sponsor's protocol ID
- TULIP TS II
- Status last verified
- Jun 2020
- First submitted
- 24 Apr 2019
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 26787795Kalil 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 20642690Kotze 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 22593128Murphy 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Transfusion on Early and Late Outcome After Major Elective Surgery
- ClinicalTrials.gov ID
- NCT03930355
- Acronym / sponsor ID
- TULIP TS II
- Conditions
- Blood Transfusion
- Keywords
- Surgery, Perioperative, Transfusion, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,121 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A secondary analysis of the Turkish National Perioperative Transfusion Study (TULIP TS) database will be performed.
Detailed description
The Turkish National Perioperative Transfusion Study (TULIP TS) was conducted by The Turkish Society of Anesthesiologists' Multicentre Clinical Trials Network.
TULIP TS included 6481 patients undergoing major elective surgery, from 61 study sites across the country.
Transfusion practices of clinicians working at diverse surgical fields; differences between current transfusion practices and patient blood management strategies; the areas for improvement and the obstacles that could prevent change were evaluated and identified.
Data relevant to perioperative transfusion rates of red blood cells, fresh frozen plasma and platelets, the indications for transfusion and postoperative adverse outcomes including 1 month all cause mortality was obtained.
The TULIP TS group aims to collect further data concerning 1 year all cause mortality of the same patient population and to evaluate adverse outcomes in transfused and non transfused patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfused | – | Other: Blood transfusionPatients who received blood transfusion in the perioperative period |
| Non transfused | – | Other: ControlPatients who did not receive blood transfusion in the perioperative period |
Who may qualify
- Ages
- 1 day to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing major elective surgery in General surgery Orthopedics Urology Transplantation surgery Neurosurgery Gynecology and obstetrics Cardiovascular surgery
Key inclusion criteria (1 listed)
- Patients undergoing major elective surgery
Key exclusion criteria (1 listed)
- Trauma patients, emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood transfusionPatients who received blood transfusion in the perioperative period | Other | Transfused |
| ControlPatients who did not receive blood transfusion in the perioperative period | Other | Non transfused |
Primary outcome
1 year all cause mortality
Time frame: postoperative 366th day
Number of participants died: all cause mortality
Acute kidney injury
Time frame: postoperative 30th day
Number of participants with acute kidney injury
Acute respiratory failure
Time frame: postoperative 30th day
Number of participants with acute respiratory failure
Thromboembolic event
Time frame: postoperative 30th day
Number of participants with a thromboembolic event
Ischemic event
Time frame: postoperative 30th day
Number of participants with an ischemic event
Infection
Time frame: postoperative 30th day
Number of participants with infection
Myocardial infarction
Time frame: postoperative 30th day
Number of participants with myocardial infarction
Adverse cardiac event
Time frame: postoperative 30th day
Number of participants with an adverse cardiac event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Background: PubMed 26787795Meier 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.
- Background: PubMed 20642690Kalil 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.
- Results publication: PubMed 22593128Kotze 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.
- Results publication: PubMed 17998460Murphy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Ünal principal investigator
Ministry of Health
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Transfusion, run by Diskapi Teaching and Research Hospital at 60 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 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 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?
1 year all cause mortality (time frame: postoperative 366th day). The study lists 8 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 NCT03930355, which also lists 4 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 24 Sep 2021.