AzTrials
AzTrials

Blood TransfusionNCT03891303

Allogenic Blood Transfusion During Elective Open Abdominal Aortic Surgery

An observational study of Blood Transfusion, run by Clinic for Cardiovascular Diseases Magdalena.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Blood Transfusion
What is being tested?
Allogenic blood transfusion (ABT)
How many people
426 participants
Where
No sites listed yet
Study dates
1 Jan 2011to 15 Oct 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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)

About this study

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

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).

Being tested
Allogenic blood transfusion (ABT)
Keywords
Aorta, abdominal, Intraoperative blood salvage, Elective surgical procedures, Patient outcomes assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03891303
Study groupRoleWhat they receive
Transfused group (TR)Group received allogenic blood transfusion (ABT) alongside with autologous blood from intraoperative cell saver (ICS) during elective open abdominal aortic surgery.
Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Retrospective analysis, 6-year period

Secondary outcomes (12)

  1. Age as the predictor of higher ABT requirement

    (years)

    Measured: Retrospective analysis, 6-year period

  2. Gender as the predictors of higher ABT requirement

    male/female

    Measured: Retrospective analysis, 6-year period

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

    BMI (kg/m2)

    Measured: Retrospective analysis, 6-year period

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

    BSA (m²)

    Measured: 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

    Measured: Retrospective analysis, 6-year period

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

    Hb (g/L) and Htc (%)

    Measured: Retrospective analysis, 6-year period

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

    abdominal aortic aneurysm or aortoiliac occlusive disease

    Measured: 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

    Measured: Retrospective analysis, 6-year period

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

    acetylsalicylic acid, clopidogrel, or warfarin

    Measured: Retrospective analysis, 6-year period

  10. Postoperative duration of mechanical ventilation

    (hours)

    Measured: Retrospective analysis, 6-year period

  11. Length of stay (LOS)

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

    Measured: Retrospective analysis, 6-year period

  12. In-hospital mortality rate

    (in %)

    Measured: Retrospective analysis, 6-year period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2019
  2. Study start1 Jan 2011
  3. Primary completion31 Dec 2016
  4. Study completion15 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
426 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03891303
Sponsor's protocol ID
ABT2011-2016
Status last verified
Mar 2019
First submitted
20 Mar 2019
Last updated
29 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Blood Transfusion, run by Clinic for Cardiovascular Diseases Magdalena.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall ABT requirement (time frame: Retrospective analysis, 6-year period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03891303, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in