Clinical trial NCT03394274: Restrictive Versus Liberal Transfusion, Major Surgeries
Official title: Restrictive Versus Liberal Transfusion for Elective Major Surgery and Perioperative Outcomes: Mortality, Morbidity and Requirement of Postoperative Blood Transfusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transfusion Related Complication
Keywords: transfusion
liberal
restrictive
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 892
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old patients,
* ASA I-II-III-IV,
* Major surgeries ( Intra-abdominal, intracranial, head and neck malignancy surgery, femur and vertebra surgery)

Exclusion Criteria:

* Emergency operation,
* Cardiovascular surgery,
* ASA V-VI
* Under 18 years old patients

Primary outcomes:
measure: Restrictive or Liberal transfusion
timeFrame: 52 weeks
Secondary outcomes:
measure: Mortality
timeFrame: 52 weeks
measure: Postoperative transfusion requirement
timeFrame: 52 Weeks
measure: The Need of ICU
timeFrame: 52 Weeks
measure: Postoperative Duration of Stay in Hospital of patients
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health sciences,sisli Hamidiye Etfal Training and Research Hospital
Study officials:
References:
citation: 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.