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Completed

NCT Number: NCT03394274

Restrictive Versus Liberal Transfusion, Major Surgeries

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.

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Key information

Conditions

Transfusion Related Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health sciences,sisli Hamidiye Etfal Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

restrictive and liberal transfusion

Other

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 .

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mortality

    Time frame: 52 weeks

    Survival ratios between the restrictive transfusion group and the liberal transfusion group are compared.

  2. Postoperative transfusion requirement

    Time frame: 52 Weeks

    The requirement of postoperative blood transfusion between the restrictive transfusion group and the liberal transfusion group is determined.

  3. The Need of ICU

    Time frame: 52 Weeks

    The need of ICU between the restrictive transfusion group and the liberal transfusion group of patients is determined.

  4. Postoperative Duration of Stay in Hospital of patients

    Time frame: 52 Weeks

    The postoperative duration of stay in hospital of patients between the restrictive transfusion group and the liberal transfusion group are compared.

Sponsors and collaborators

Lead sponsor

Leyla Kılınc

Other

Registry information

Official study title

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

Acronym: transfusion

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 9, 2018
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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