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Clinical Trials/NCT03910816
NCT03910816CompletedNot Applicable

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

University Hospital, Montpellier1 site in 1 country377 target enrollmentStarted: January 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
377
Locations
1
Primary Endpoint
Transfusion rate for each surgical procedure

Study Overview

Brief 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. 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.

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Emergency surgery
  • Age < 18

Outcomes

Primary Outcomes

Transfusion rate for each surgical procedure

Time Frame: 24 hours before surgery to 48 hours after surgery

transfused patients / total number of procedures performed

Secondary Outcomes

  • hemorrhagic risk(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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