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Restrictive Versus Liberal Transfusion, Major Surgeries

Restrictive Versus Liberal Transfusion for Elective Major Surgery and Perioperative Outcomes: Mortality, Morbidity and Requirement of Postoperative Blood Transfusion

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03394274
Acronym
transfusion
Enrollment
892
Registered
2018-01-09
Start date
2017-06-14
Completion date
2017-11-15
Last updated
2018-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transfusion Related Complication

Keywords

transfusion, liberal, restrictive

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.

Interventions

OTHERrestrictive and liberal transfusion

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 .

Sponsors

Leyla Kılınc
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Restrictive or Liberal transfusion52 weeksIt 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.

Secondary

MeasureTime frameDescription
Mortality52 weeksSurvival ratios between the restrictive transfusion group and the liberal transfusion group are compared.
Postoperative transfusion requirement52 WeeksThe requirement of postoperative blood transfusion between the restrictive transfusion group and the liberal transfusion group is determined.
The Need of ICU52 WeeksThe need of ICU between the restrictive transfusion group and the liberal transfusion group of patients is determined.
Postoperative Duration of Stay in Hospital of patients52 WeeksThe postoperative duration of stay in hospital of patients between the restrictive transfusion group and the liberal transfusion group are compared.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026