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Completed

NCT Number: NCT03891303

Allogenic Blood Transfusion During Elective Open Abdominal Aortic Surgery

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.

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Allogenic blood transfusion (ABT)

Other

During elective open aortic surgery, the autologous blood from ICS was processed and re-transfused in all patients. However, TR group additionally received ABT.

Primary outcomes

  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 outcomes

  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 %)

Sponsors and collaborators

Lead sponsor

Clinic for Cardiovascular Diseases Magdalena

Network

Registry information

Official study title

Allogenic Blood Transfusion During Elective Open Abdominal Aortic Surgery and Its Predictors: a Retrospective Database Study at a Tertiary Hospital in Croatia

Important dates

Study start
2011
Primary completion
2016
Study completion
2018
First posted
Mar 27, 2019
Registry last updated
Mar 29, 2019

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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