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CompletedNCT03394274transfusionUpdated Jan 11, 2018

Restrictive Versus Liberal Transfusion, Major Surgeries

An observational study in Transfusion Related Complication, sponsored by Leyla Kılınc. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-11.

Sponsored by Leyla Kılınc · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
892
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Transfusion Related Complication

Keywords

  • transfusion
  • liberal
  • restrictive
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Emergency operation,
  • Cardiovascular surgery,
  • ASA V-VI
  • Under 18 years old patients
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
892 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Other: restrictive and liberal transfusion

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 .

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 52 weeks

Secondary outcomes

  1. Mortality

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

    Time frame: 52 weeks

  2. Postoperative transfusion requirement

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

    Time frame: 52 Weeks

  3. The Need of ICU

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

    Time frame: 52 Weeks

  4. 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.

    Time frame: 52 Weeks

06

Study locations

1 site
  • University of Health sciences,sisli Hamidiye Etfal Training and Research Hospital
    Istanbul, 34371, Turkey
07

References and documents

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 ↗

Individual participant data

Plan to share: No — there is no plan to make individual participant data (IPD) available to other researchers.

08

Registry details

Key details

Study ID
NCT03394274
Lead sponsor
Leyla Kılınc
Responsible party
Leyla Kılınc (medical doctor, anesthesiology specialist, Sisli Hamidiye Etfal Training and Research Hospital) — Sponsor-investigator
First posted
Jan 9, 2018
Start date
Jun 14, 2017
Primary completion
Sep 15, 2017
Completion
Nov 15, 2017
Last update
Jan 11, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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