Scheduled SurgeryTHANKSNCT03910816
Transfusion HeAd NecK Surgery
An observational study of Scheduled Surgery, run by University Hospital, Montpellier at 1 site in France.
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.
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.
- Conditions
- Scheduled Surgery
- Keywords
- Surgery, Eighteen
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted10 Apr 2019
- Study start1 Jan 2015
- Primary completion1 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scheduled SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Pathology & Cell Biology - 630 West 168th Street - P&S 14-434 - New York, NY 10032
- Responsible party
- Sponsor
- Investigators
- Rapido Francesca, MD, Study director, University Hospital, Montpellier
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemorrhagic Risk and Transfusion Practice Evaluation in Elective Head, Neck and Spine Surgery.
- ClinicalTrials.gov ID
- NCT03910816
- Acronym / sponsor ID
- THANKS / RECHMPL18_0352
- Conditions
- Scheduled Surgery
- Keywords
- Surgery, Eighteen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Department of Pathology & Cell Biology - 630 West 168th Street - P&S 14-434 - New York, NY 10032
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- scheduled surgery between 1st Jan 2015 and 31st Dec 2017
- age > 18
Key exclusion criteria (2 listed)
- Emergency surgery
- Age < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transfusion rate for each surgical procedure
Time frame: 24 hours before surgery to 48 hours after surgery
transfused patients / total number of procedures performed
1 secondary outcome
hemorrhagic risk
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rapido Francesca, MD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
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.