Preoperative Assessment of HemostasisHEMOSTASENCT02886117
Auto-administered Questionnaire by Screening of Disorder of the Haemostasis in Preoperative
An observational study of Preoperative Assessment of Hemostasis, run by University Hospital, Brest at 1 site in France.
Trial summary
The main objective of this study is to determine the capacity of a questionnaire to predict a normal balance sheet of haemostasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Assessment of Hemostasis
- How many people
- 2,511 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Aug 2015
- 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: General population coming in programmed anesthesia consultation
Who may be able to join
- All adults addressed in programmed anesthesia consultation, regardless of whether surgery and consultation site
Who cannot join
- Patients minors
- Physical or mental disability in Patient to agree and complete the questionnaire
- Major patients undergoing a protective measure
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Creation and Evaluation of a Auto-administered Questionnaire by Screening of Disorder of the Haemostasis in Preoperative
The main objective of this study is to determine the capacity of a questionnaire to predict a normal balance sheet of haemostasis.
Read the detailed description
Recent recommendations formalized by experts of the French society of anaesthesiology on systematic pre-interventional examinations recommend assessing the risk of bleeding from personal and family history of bleeding diathesis and after physical examination . They recommend not to prescribe a systematic hemostasis laboratory tests in patients with a history and physical examination do not suspect a disorder of hemostasis.
However, there is currently no validated questionnaire in the general population to assess the preoperative bleeding risk allowing a reliable assessment of the personal and family bleeding diathesis.
The establishment of a structured questionnaire, the patient could filled before surgery consultation to guide the possible prescription of a balance sheet, could meet the new recommendations.
It seems therefore important to establish this type of questionnaire in order to optimize the operation of the structure, and to limit the requirements of routine hemostasis balance sheets. To do this, the investigator wants to carry out a preliminary study to ensure the interest of the established questionnaire.
The questionnaire assessed in this study is drawn from existing specialized questionnaires, the description of hemostasis disorders described factor for deficits from the doctor in charge of hemophilia expertise center and expertise of a psychologist, to refine best.
- Conditions
- Preoperative Assessment of Hemostasis
What is being measured
The primary outcome is the main question the study is designed to answer.
hemostasis tests (normal or abnormal)
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Assessment of HemostasisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,511 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Ozier, Professor, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886117
- Sponsor's protocol ID
- TROUBLE HEMOSTASE (RB 14.121)
- Acronym
- HEMOSTASE
- Status last verified
- Aug 2016
- First submitted
- 29 Aug 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation and Evaluation of a Auto-administered Questionnaire by Screening of Disorder of the Haemostasis in Preoperative
- ClinicalTrials.gov ID
- NCT02886117
- Acronym / sponsor ID
- HEMOSTASE / TROUBLE HEMOSTASE (RB 14.121)
- Conditions
- Preoperative Assessment of Hemostasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,511 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Sep 2016 (estimated)
- 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.
The main objective of this study is to determine the capacity of a questionnaire to predict a normal balance sheet of haemostasis.
Detailed description
Recent recommendations formalized by experts of the French society of anaesthesiology on systematic pre-interventional examinations recommend assessing the risk of bleeding from personal and family history of bleeding diathesis and after physical examination . They recommend not to prescribe a systematic hemostasis laboratory tests in patients with a history and physical examination do not suspect a disorder of hemostasis.
However, there is currently no validated questionnaire in the general population to assess the preoperative bleeding risk allowing a reliable assessment of the personal and family bleeding diathesis.
The establishment of a structured questionnaire, the patient could filled before surgery consultation to guide the possible prescription of a balance sheet, could meet the new recommendations.
It seems therefore important to establish this type of questionnaire in order to optimize the operation of the structure, and to limit the requirements of routine hemostasis balance sheets. To do this, the investigator wants to carry out a preliminary study to ensure the interest of the established questionnaire.
The questionnaire assessed in this study is drawn from existing specialized questionnaires, the description of hemostasis disorders described factor for deficits from the doctor in charge of hemophilia expertise center and expertise of a psychologist, to refine best.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population coming in programmed anesthesia consultation
Key inclusion criteria (1 listed)
- All adults addressed in programmed anesthesia consultation, regardless of whether surgery and consultation site
Key exclusion criteria (4 listed)
- Patients minors
- Physical or mental disability in Patient to agree and complete the questionnaire
- Major patients undergoing a protective measure
- Refusal of participation
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
hemostasis tests (normal or abnormal)
Time frame: Inclusion
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 1 Sep 2016.
Related trials for Preoperative Assessment of Hemostasis
RecruitingObservational study
External Multicenter Validation of the APTTO Model for Prolonged APTT Using Clot Waveform Analysis
Coagulation Disorder, Blood, Prolonged APTT
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.
Yves Ozier, Professor principal investigator
CHRU de Brest
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 Preoperative Assessment of Hemostasis, run by University Hospital, Brest 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 1 inclusion and 4 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 1 Sep 2016. 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?
hemostasis tests (normal or abnormal) (time frame: Inclusion). 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 1 Sep 2016.