Transfusion HeAd NecK Surgery (THANKS)

University Hospital Center (CHU)

Status

Completed

Conditions

Scheduled Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT03910816

RECHMPL18_0352

Details and patient eligibility

About

During elective surgery, the decision to transfuse a patient to correct anemia or an unstable hemodynamic state is often determined on a case by case basis according to personal and hospital transfusion practice. There is wide variability in these practices. Literature suggests that a restrictive transfusion practice is equivalent, if not better, than a liberal practice in terms of morbidity and mortality. However, these data may not be generalizable to specific head, neck, and spine surgeries.

At the head and neck department of Montpellier University Hospital, the hemorrhagic risk has not been precisely measured for certain surgical procedures. Thus hemorrhagic risk tends to be overestimated and unnecessary blood tests tend to be ordered.

In our single center, retrospective, observational study the investigators will determine the hemorrhagic risk related to each elective surgical procedure performed in our center. The investigators will also analyze the transfusion triggers used, and will compare them to national and international recommendations. The results of this study will inform transfusion and laboratory practice for patients undergoing head, neck, or spine surgery.

Full description

Our single center, retrospective, observational study will analyze the transfusion practices at the Montpellier University Hospital during the perioperative period (defined as 24 hours before surgery to 48 hours after surgery).

Aim of the study The aim of the study is to identify the transfusion rate for each surgical procedure (transfused patients / total number of procedures performed).

The study will also allow us:

to identify the hemorrhagic risk related to each surgical procedure performed;
to define the triggers for and factors determining transfusions of PRBC and others bloods products, according to the surgical procedure and to the patient's caracteristicus;
to assessee the quality of transfusion practices according to the national and international recommendations;
to evaluate the accuracy of the preoperative bleeding risk estimation;
to check the traceability of the transfusions in our department;
to evaluate the length of hospital stay (LOS) and the 30-days outcome of transfused patients

Starting from these objectives, a model of transfusion management could be defined.

Also, requests of pre-transfusion blood test could be limited, reducing the costs associated with transfusion management.

Definition of the population This is an observational monocentric retrospective study. All the patients undergoing to a scheduled surgical procedure at the Montpellier University Hospital, head and neck department, between 01-01-2015 and 31-12-2017.

The scheduled surgery will be defined as performed at least 48 hours after the indication given by the surgeon.

The only exclusion criteria will be age < 18 years and emergency surgery patients.

Data circuit definition All data will come from our computerized medical records. A complete list of transfused patients for this period will be requested to the hospital transfusion center.

Each patient will be renamed with a progressive numeric code and the database will be saved in a password-protected hospital computer. The data will be read and analyzed exclusively on Montpellier University Hospital's computers by people

Data collection

The following data will be collected for each patient:

Demographic data

Name, hospital ID
Age, sex, weight, height, BMI, ASA classification
Reason for hospitalization, type and day of surgery
Emergency surgery during the hospitalisation
Duration of anesthesia
Existing co-morbidities (especially liver and coagulation diseases, anemia, chronic inflammatory bowel diseases and diseases influencing the level of hemoglobin and coagulation)
Anti-aggregating treatments, personal anticoagulants at risk of haemorrhage

Biological data

Basal Hb, Ht, INR, ACT, aPTT, platelets count, fibrinogen, albumin, liver function, lactate and SvO2
Hb, Ht, INR, ACT, aPTT, platelets count, fibrinogen, albumin, liver function, lactate and SvO2 at the beginning of the surgery, before (period of 30 min) transfusion PRBC and at the end of procedure

Parameters and drugs

Vital signs, use of vasoactive drugs at the beginning of the surgery, before (period of 30 min) transfusion PRBC and at the end of procedure
Cardiac events or other incidents before (period of 30 min) transfusion
Estimated blood loss
Volume of crystalloids, colloids, labile blood products administered
Estimated loss of volume until the end of the surgery (blood loss, Urine, other liquids)
Input-output balance
Use of: tranexamic acid, PPSB, fibrinogen, Factor VIIa, cryoprecipitate, factor XIII, cell saver
Traceability of the transfusion

Follow-up