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CompletedNCT03891303Updated Mar 29, 2019

Allogenic Blood Transfusion During Elective Open Abdominal Aortic Surgery

An observational study in Blood Transfusion, sponsored by Clinic for Cardiovascular Diseases Magdalena. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-03-29.

Sponsored by Clinic for Cardiovascular Diseases Magdalena · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
426
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Blood Transfusion

Keywords

  • Aorta, abdominal
  • Intraoperative blood salvage
  • Elective surgical procedures
  • Patient outcomes assessment
03

In context

Lead sponsor

This is the only study on the registry with Clinic for Cardiovascular Diseases Magdalena as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
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.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
426 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

  • Non-transfused (non-TR)

    Group received only autologous blood from intraoperative cell saver (ICS) during elective open abdominal aortic surgery.

Interventions

  • OtherAllogenic 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.

06

What researchers measure

Primary outcomes

  1. Overall ABT requirement

    Overall ABT requirement (in %) during elective abdominal aortic surgery with the use of ICS for intraoperative blood salvage and autologous transfusion.

    Time frame: Retrospective analysis, 6-year period

Secondary outcomes

  1. Age as the predictor of higher ABT requirement

    (years)

    Time frame: Retrospective analysis, 6-year period

  2. Gender as the predictors of higher ABT requirement

    male/female

    Time frame: Retrospective analysis, 6-year period

  3. Body mass index (BMI) as the predictors of higher ABT requirement

    BMI (kg/m2)

    Time frame: Retrospective analysis, 6-year period

  4. Body surface area (BSA) as the predictors of higher ABT requirement

    BSA (m²)

    Time frame: Retrospective analysis, 6-year period

  5. Total blood volume as the possible predictors of higher ABT requirement

    TBV (in liters) calculated trough Nadler's formula

    Time frame: Retrospective analysis, 6-year period

  6. Hemoglobin (Hb) and hematocrit (Htc) as the predictors of higher ABT requirement

    Hb (g/L) and Htc (%)

    Time frame: Retrospective analysis, 6-year period

  7. Type of illness as the predictor of higher ABT requirement

    abdominal aortic aneurysm or aortoiliac occlusive disease

    Time frame: Retrospective analysis, 6-year period

  8. Patient's comorbidities as the predictors of higher ABT requirement

    arterial hypertension, coronary artery disease, diabetes, atrial fibrillation, cerebrovascular incidents, chronic obstructive pulmonary disease, chronic renal insufficiency, malignancy

    Time frame: Retrospective analysis, 6-year period

  9. Medications that impair coagulation and homeostasis as the predictor of higher ABT requirement

    acetylsalicylic acid, clopidogrel, or warfarin

    Time frame: Retrospective analysis, 6-year period

  10. Postoperative duration of mechanical ventilation

    (hours)

    Time frame: Retrospective analysis, 6-year period

  11. Length of stay (LOS)

    LOS in ICU (days) and overall hospital LOS (days)

    Time frame: Retrospective analysis, 6-year period

  12. In-hospital mortality rate

    (in %)

    Time frame: Retrospective analysis, 6-year period

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Kent KC, Zwolak RM, Egorova NN, Riles TS, Manganaro A, Moskowitz AJ, Gelijns AC, Greco G. Analysis of risk factors for abdominal aortic aneurysm in a cohort of more than 3 million individuals. J Vasc Surg. 2010 Sep;52(3):539-48. doi: 10.1016/j.jvs.2010.05.090. Epub 2010 Jul 13. PubMed 20630687 ↗
  • Ashworth A, Klein AA. Cell salvage as part of a blood conservation strategy in anaesthesia. Br J Anaesth. 2010 Oct;105(4):401-16. doi: 10.1093/bja/aeq244. Epub 2010 Aug 28. PubMed 20802228 ↗
  • Roubinian NH, Murphy EL, Swain BE, Gardner MN, Liu V, Escobar GJ; NHLBI Recipient Epidemiology and Donor Evaluation Study-III (REDS-III); Northern California Kaiser Permanente DOR Systems Research Initiative. Predicting red blood cell transfusion in hospitalized patients: role of hemoglobin level, comorbidities, and illness severity. BMC Health Serv Res. 2014 May 10;14:213. doi: 10.1186/1472-6963-14-213. PubMed 24884605 ↗
  • Bursi F, Barbieri A, Politi L, Di Girolamo A, Malagoli A, Grimaldi T, Rumolo A, Busani S, Girardis M, Jaffe AS, Modena MG. Perioperative red blood cell transfusion and outcome in stable patients after elective major vascular surgery. Eur J Vasc Endovasc Surg. 2009 Mar;37(3):311-8. doi: 10.1016/j.ejvs.2008.12.002. Epub 2008 Dec 25. PubMed 19111480 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03891303
Lead sponsor
Clinic for Cardiovascular Diseases Magdalena
Responsible party
Katarina Tomulic Brusich (Principal Investigator, Clinic for Cardiovascular Diseases Magdalena) — Principal investigator
First posted
Mar 27, 2019
Start date
Jan 1, 2011
Primary completion
Dec 31, 2016
Completion
Oct 15, 2018
Last update
Mar 29, 2019

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 Mar 2019. You cannot join it, but the record below documents what was studied.

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