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Allogenic Blood Transfusion During Elective Open Abdominal Aortic Surgery

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ClinicalTrials.gov Identifier: NCT03891303
Recruitment Status : Completed
First Posted : March 27, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Katarina Tomulic Brusich, Clinic for Cardiovascular Diseases Magdalena

Brief Summary:

Open surgery on the abdominal aorta is a high risk procedure associated with an intravascular volume blood loss and thereby, with high requirement for blood and blood product transfusion.

The aim of this study was to establish the rate for allogenic blood transfusion (ABT) during elective open abdominal aortic surgery and find parameters associated with ABT requirements.


Condition or disease Intervention/treatment
Blood Transfusion Other: Allogenic blood transfusion (ABT)

Detailed Description:

Two distinct clinical entities affect the abdominal aorta: abdominal aortic aneurysm (AAA) and aortoiliac occlusive disease (AIOD). These are multifactorial vascular disorders caused by complex genetic and environmental factors. Older patients with more comorbidity are often affected. Open abdominal aortic surgery is associated with high mortality rate. Even in specialised institutions it varies from 2 to 5%. Similar results can be compared to mortality for coronary artery bypass grafting. This reflects the complexity of the surgery and the general health of those patients. It is associated with intravascular volume blood loss and, thereby, with a high requirement for blood and blood products transfusion. Allogenic blood transfusion (ABT) has been associated with an increased risk of tumour recurrence, postoperative infection, acute lung injury, perioperative myocardial infarction, postoperative low-output cardiac failure, and increased mortality.

In the last decades, multiple strategies have been undertaken to prevent massive intraoperative blood loss during elective surgery and allogenic blood transfusion requirement. One of the method advocates a preoperative increase in red blood cells level using B12, folic acid and iron supplements or with erythropoietin usage. Other methods involve the optimisation of surgical technique and the use of a machine for intraoperative blood salvage, known as "cell saver".

The aim of this study was to establish the rate for ABT during elective open abdominal aortic surgery, find parameters associated with ABT requirements, and optimise the investigators hospital's maximum surgical blood ordering schedule (MSBOS).

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Study Type : Observational
Actual Enrollment : 426 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Allogenic Blood Transfusion During Elective Open Abdominal Aortic Surgery and Its Predictors: a Retrospective Database Study at a Tertiary Hospital in Croatia
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Transfused group (TR)
Group received allogenic blood transfusion (ABT) alongside with autologous blood from intraoperative cell saver (ICS) during elective open abdominal aortic surgery.
Other: Allogenic blood transfusion (ABT)
During elective open aortic surgery, the autologous blood from ICS was processed and re-transfused in all patients. However, TR group additionally received ABT.

Non-transfused (non-TR)
Group received only autologous blood from intraoperative cell saver (ICS) during elective open abdominal aortic surgery.



Primary Outcome Measures :
  1. Overall ABT requirement [ Time Frame: Retrospective analysis, 6-year period ]
    Overall ABT requirement (in %) during elective abdominal aortic surgery with the use of ICS for intraoperative blood salvage and autologous transfusion.


Secondary Outcome Measures :
  1. Age as the predictor of higher ABT requirement [ Time Frame: Retrospective analysis, 6-year period ]
    (years)

  2. Gender as the predictors of higher ABT requirement [ Time Frame: Retrospective analysis, 6-year period ]
    male/female

  3. Body mass index (BMI) as the predictors of higher ABT requirement [ Time Frame: Retrospective analysis, 6-year period ]
    BMI (kg/m2)

  4. Body surface area (BSA) as the predictors of higher ABT requirement [ Time Frame: Retrospective analysis, 6-year period ]
    BSA (m²)

  5. Total blood volume as the possible predictors of higher ABT requirement [ Time Frame: Retrospective analysis, 6-year period ]
    TBV (in liters) calculated trough Nadler's formula

  6. Hemoglobin (Hb) and hematocrit (Htc) as the predictors of higher ABT requirement [ Time Frame: Retrospective analysis, 6-year period ]
    Hb (g/L) and Htc (%)

  7. Type of illness as the predictor of higher ABT requirement [ Time Frame: Retrospective analysis, 6-year period ]
    abdominal aortic aneurysm or aortoiliac occlusive disease

  8. Patient's comorbidities as the predictors of higher ABT requirement [ Time Frame: Retrospective analysis, 6-year period ]
    arterial hypertension, coronary artery disease, diabetes, atrial fibrillation, cerebrovascular incidents, chronic obstructive pulmonary disease, chronic renal insufficiency, malignancy

  9. Medications that impair coagulation and homeostasis as the predictor of higher ABT requirement [ Time Frame: Retrospective analysis, 6-year period ]
    acetylsalicylic acid, clopidogrel, or warfarin

  10. Postoperative duration of mechanical ventilation [ Time Frame: Retrospective analysis, 6-year period ]
    (hours)

  11. Length of stay (LOS) [ Time Frame: Retrospective analysis, 6-year period ]
    LOS in ICU (days) and overall hospital LOS (days)

  12. In-hospital mortality rate [ Time Frame: Retrospective analysis, 6-year period ]
    (in %)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A retrospective cross-sectional study was conducted using an existing computerised medical records database at the Department of Anaesthesiology and Intensive Care at the Clinic for Cardiovascular Diseases Magdalena. This Clinic is a tertiary hospital in Croatia specialised in cardiac and vascular surgery. This study is a retrospective analysis of consecutive patients undergoing elective major vascular surgery who had been prospectively risk-stratified.
Criteria

Inclusion Criteria:

  • Patients older than 18 years
  • Elective open abdominal aortic surgery
  • Abdominal aortic aneurysm repair
  • Abdominal aortic bypass grafting for occlusive aortoiliac disease

Exclusion Criteria:

  • Patients younger than 18 years
  • Patients undergoing cardiac surgery
  • Patients with ruptured abdominal aneurysms
  • Patients undergoing endovascular aortic repair
  • Patients submitted to other types of vascular surgery (i.e., carotid endarterectomy or peripheral bypass surgery)
Publications:
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Responsible Party: Katarina Tomulic Brusich, Principal Investigator, Clinic for Cardiovascular Diseases Magdalena
ClinicalTrials.gov Identifier: NCT03891303    
Other Study ID Numbers: ABT2011-2016
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Katarina Tomulic Brusich, Clinic for Cardiovascular Diseases Magdalena:
Aorta, abdominal
Intraoperative blood salvage
Elective surgical procedures
Patient outcomes assessment