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Restrictive Versus Liberal Transfusion, Major Surgeries (transfusion)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394274
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Leyla Kılınc, Sisli Hamidiye Etfal Training and Research Hospital

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.

Condition or disease Intervention/treatment
Transfusion Related Complication Other: restrictive and liberal transfusion

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.

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Study Type : Observational
Actual Enrollment : 892 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Restrictive Versus Liberal Transfusion for Elective Major Surgery and Perioperative Outcomes: Mortality, Morbidity and Requirement of Postoperative Blood Transfusion
Actual Study Start Date : June 14, 2017
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394274


Locations
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Turkey
University of Health sciences,sisli Hamidiye Etfal Training and Research Hospital
Istanbul, Turkey, 34371
Sponsors and Collaborators
Leyla Kılınc
Publications:
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Responsible Party: Leyla Kılınc, medical doctor, anesthesiology specialist, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03394274    
Other Study ID Numbers: 814
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there is no plan to make individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leyla Kılınc, Sisli Hamidiye Etfal Training and Research Hospital:
transfusion
liberal
restrictive