Auto-administered Questionnaire by Screening of Disorder of the Haemostasis in Preoperative

Preoperative Assessment of Hemostasis Clinical Trial

— HEMOSTASE  

Official title:

Creation and Evaluation of a Auto-administered Questionnaire by Screening of Disorder of the Haemostasis in Preoperative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886117
• Other study ID #: TROUBLE HEMOSTASE (RB 14.121)
• Status: Completed
• Phase: N/A
• First received: August 29, 2016
• Last updated: August 31, 2016
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2016
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

The main objective of this study is to determine the capacity of a questionnaire to predict a normal balance sheet of haemostasis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2511
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adults addressed in programmed anesthesia consultation, regardless of whether surgery and consultation site

Exclusion Criteria:

• Patients minors

• Physical or mental disability in Patient to agree and complete the questionnaire

• Major patients undergoing a protective measure

• Refusal of participation

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Preoperative Assessment of Hemostasis

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemostasis tests (normal or abnormal)		Inclusion	No