AzTrials
AzTrials

Scheduled SurgeryTHANKSNCT03910816

Transfusion HeAd NecK Surgery

An observational study of Scheduled Surgery, run by University Hospital, Montpellier at 1 site in France.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Scheduled Surgery
How many people
377 participants
Where
1 siteFrance
Study dates
1 Jan 2015to 31 Dec 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients who have had scheduled surgery at the Gui de Chauliac Hospital between 01-01-2015 and 31-12-2017

Who may be able to join

  • scheduled surgery between 1st Jan 2015 and 31st Dec 2017
  • age > 18

Who cannot join

  • Emergency surgery
  • Age < 18

Trial locations and contacts

1 site in 1 country.

France1 site
  • Uhmontpellier

    Montpellier, 34295

Other trials in France

About this study

Official title: Hemorrhagic Risk and Transfusion Practice Evaluation in Elective Head, Neck and Spine Surgery.

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.

Read the detailed 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

  • Blood transfusions during the follow-up period and reason for transfusion
  • ICU stay (duration, complications, hours of mechanical ventilation)
  • LOS at the hospital
  • Mortality at the hospital
  • Patient 30-day survival

The end of the follow-up is defined by the hospital discharge or by the 30th postoperative day.

Statistical management of data

This study is observational retrospective, no intervention of the patient will take place, only descriptive statistical methods will be used.

Future development This database could be the basis for a second study, comparing data from not-transfused patients undergoing to the same surgery.

These results could be also at the origin of a prospective randomized controlled study concerning the transfusion practice in our center.

Keywords
Surgery, Eighteen

What is being measured

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

  1. Transfusion rate for each surgical procedure

    transfused patients / total number of procedures performed

    Measured: 24 hours before surgery to 48 hours after surgery

Secondary outcomes (1)
  1. hemorrhagic risk

    Estimation of bleeding risk by checking the ratio between the number of groups / RAI required and the number of patients transfused

    Measured: 1 day

Timeline

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

  1. First posted10 Apr 2019
  2. Study start1 Jan 2015
  3. Primary completion1 Dec 2017
  4. Study completion31 Dec 2017

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
377 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03910816
Sponsor's protocol ID
RECHMPL18_0352
Acronym
THANKS
Status last verified
Mar 2019
First submitted
25 Mar 2019
Last updated
10 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: NC

Questions about this trial

What is this clinical trial studying?

An observational study of Scheduled Surgery, run by University Hospital, Montpellier at 1 site in France.

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 2 inclusion and 2 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 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Transfusion rate for each surgical procedure (time frame: 24 hours before surgery to 48 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Apr 2019.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in