Transfusion Related ComplicationtransfusionNCT03394274
Restrictive Versus Liberal Transfusion, Major Surgeries
An observational study of Transfusion Related Complication, run by Leyla Kılınc at 1 site in Turkey (Türkiye).
Trial summary
Investigators aimed to compare the restrictive and liberal blood transfusion methods applied in major surgical operations performed in Anesthesiology and Reanimation Clinic and investigate their effects on postoperative transfusion needs, morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfusion Related Complication
- What is being tested?
- restrictive and liberal transfusion
- How many people
- 892 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jun 2017to 15 Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Over 18 years old patients, ASA I-II-III-IV, major surgeries ( Intraabdominal, intracranial, head and neck malignanacy surgery, femur and vertebra surgery) were enrolled.
Who may be able to join
- Over 18 years old patients,
- ASA I-II-III-IV,
- Major surgeries ( Intra-abdominal, intracranial, head and neck malignancy surgery, femur and vertebra surgery)
Who cannot join
- Emergency operation,
- Cardiovascular surgery,
- ASA V-VI
- Under 18 years old patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health sciences,sisli Hamidiye Etfal Training and Research Hospital
Istanbul, 34371
About this study
Official title: Restrictive Versus Liberal Transfusion for Elective Major Surgery and Perioperative Outcomes: Mortality, Morbidity and Requirement of Postoperative Blood Transfusion
Investigators aimed to compare the restrictive and liberal blood transfusion methods applied in major surgical operations performed in Anesthesiology and Reanimation Clinic and investigate their effects on postoperative transfusion needs, morbidity and mortality.
Read the detailed description
The test subjects consisted of 892 patients, who belong to ASA (American society of Anesthesiology) I -IV groups, underwent elective major surgery between the 01/01/2016-31/12/2016, and are over the age of 18 years. The demographic data (Age, sex, ASA (American society of Anesthesiology) scors, surgery type) were also recorded. we evaluated the value of Hemoglobin, platelet, APTT (activated partial thromboplastin time), INR (international normalized ratio) preoperatively and postoperatively. In this study, restrictive and liberal blood transfusion groups were investigated.restrictive and liberal transfusion hemoglobin threshold value respectively before perioperative transfusion was 8 g / dL. were defined as restrictive blood transfusion group and perioperative transfusion was over 8 g / dL were defined as liberal blood transfusion group. Adverse events (tachycardia, hypotension, the value of lactate and metabolic acidosis). Postoperatively, the amount of postoperative transfusion unit, duration of hospital stay, requirement of intensive care unit and mortality rate.
- Conditions
- Transfusion Related Complication
- Being tested
- restrictive and liberal transfusion
- Keywords
- transfusion, liberal, restrictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restrictive and liberal transfusionOther
hemoglobin threshold value was accepted 8g/dl. restrictive blood transfusion group was defined that if perioperative transfusion was started equal or under hemoglobin level 8 g / dL. Liberal blood transfusion group was defined as perioperative transfusion was started over hemoglobin level 8 g / dL .
| Study group | Role | What they receive |
|---|---|---|
| Transfusion | Patients (n:892) were enrolled who underwent elective major surgery between the 01/01/2016-31/12/2016, and over the age of 18 years. They separated subgroups as restrictive and liberal blood transfusion groups Receives: Other: restrictive and liberal transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restrictive or Liberal transfusion
It is determined how many units of RBC (red blood cell ) used during major operations at the hospital in liberal transfusion group or restrictive transfusion group.
Measured: 52 weeks
Secondary outcomes (4)
Mortality
Survival ratios between the restrictive transfusion group and the liberal transfusion group are compared.
Measured: 52 weeks
Postoperative transfusion requirement
The requirement of postoperative blood transfusion between the restrictive transfusion group and the liberal transfusion group is determined.
Measured: 52 Weeks
The Need of ICU
The need of ICU between the restrictive transfusion group and the liberal transfusion group of patients is determined.
Measured: 52 Weeks
Postoperative Duration of Stay in Hospital of patients
The postoperative duration of stay in hospital of patients between the restrictive transfusion group and the liberal transfusion group are compared.
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start14 Jun 2017
- Primary completion15 Sep 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transfusion Related ComplicationStudies 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
- Retrospective
- Enrolment
- 892 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leyla Kılınc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leyla Kılınc, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394274
- Sponsor's protocol ID
- 814
- Acronym
- transfusion
- Status last verified
- Jan 2018
- First submitted
- 27 Nov 2017
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no plan to make individual participant data (IPD) available to other researchers.
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 26787795
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restrictive Versus Liberal Transfusion for Elective Major Surgery and Perioperative Outcomes: Mortality, Morbidity and Requirement of Postoperative Blood Transfusion
- ClinicalTrials.gov ID
- NCT03394274
- Acronym / sponsor ID
- transfusion / 814
- Conditions
- Transfusion Related Complication
- Keywords
- transfusion, liberal, restrictive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 892 participants (actual)
- Lead sponsor
- Leyla KılıncUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 9 Jan 2018 (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.
Investigators aimed to compare the restrictive and liberal blood transfusion methods applied in major surgical operations performed in Anesthesiology and Reanimation Clinic and investigate their effects on postoperative transfusion needs, morbidity and mortality.
Detailed description
The test subjects consisted of 892 patients, who belong to ASA (American society of Anesthesiology) I -IV groups, underwent elective major surgery between the 01/01/2016-31/12/2016, and are over the age of 18 years. The demographic data (Age, sex, ASA (American society of Anesthesiology) scors, surgery type) were also recorded. we evaluated the value of Hemoglobin, platelet, APTT (activated partial thromboplastin time), INR (international normalized ratio) preoperatively and postoperatively. In this study, restrictive and liberal blood transfusion groups were investigated.restrictive and liberal transfusion hemoglobin threshold value respectively before perioperative transfusion was 8 g / dL. were defined as restrictive blood transfusion group and perioperative transfusion was over 8 g / dL were defined as liberal blood transfusion group. Adverse events (tachycardia, hypotension, the value of lactate and metabolic acidosis). Postoperatively, the amount of postoperative transfusion unit, duration of hospital stay, requirement of intensive care unit and mortality rate.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transfusion | – | Other: restrictive and liberal transfusionPatients (n:892) were enrolled who underwent elective major surgery between the 01/01/2016-31/12/2016, and over the age of 18 years. They separated subgroups as restrictive and liberal blood transfusion groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Over 18 years old patients, ASA I-II-III-IV, major surgeries ( Intraabdominal, intracranial, head and neck malignanacy surgery, femur and vertebra surgery) were enrolled.
Key inclusion criteria (3 listed)
- Over 18 years old patients,
- ASA I-II-III-IV,
- Major surgeries ( Intra-abdominal, intracranial, head and neck malignancy surgery, femur and vertebra surgery)
Key exclusion criteria (4 listed)
- Emergency operation,
- Cardiovascular surgery,
- ASA V-VI
- Under 18 years old patients
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 |
|---|---|---|
| restrictive and liberal transfusionhemoglobin threshold value was accepted 8g/dl. restrictive blood transfusion group was defined that if perioperative transfusion was started equal or under hemoglobin level 8 g / dL. Liberal blood transfusion group was defined as perioperative transfusion was started over hemoglobin level 8 g / dL . | Other | Transfusion |
Primary outcome
Restrictive or Liberal transfusion
Time frame: 52 weeks
It is determined how many units of RBC (red blood cell ) used during major operations at the hospital in liberal transfusion group or restrictive transfusion group.
4 secondary outcomes
Mortality
Time frame: 52 weeks
Postoperative transfusion requirement
Time frame: 52 Weeks
The Need of ICU
Time frame: 52 Weeks
Postoperative Duration of Stay in Hospital of patients
Time frame: 52 Weeks
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 11 Jan 2018.
- 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.
- Individual participant dataSharing planned: No. there is no plan to make individual participant data (IPD) available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transfusion Related Complication, run by Leyla Kılınc at 1 site 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 3 inclusion and 4 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 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Restrictive or Liberal transfusion (time frame: 52 weeks). 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 NCT03394274, which also lists 1 linked publication.
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 11 Jan 2018; AzTrials last refreshed its copy on 30 Oct 2026.