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Pre-operative Haemorrhagic Risk Screening, Using a Standardized Questionnaire Before Scheduled Surgeries

NCT02617381 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2020-03-12

No results posted yet for this study

Summary

"This is not a validation study of a questionnaire. This is a multicenter diagnostic study, assessing the sensitivity and specificity of a simple structured questionnaire, to identify patients requiring further haemostatic investigations, in pre-operative patients. This study will also allow for the assessment of the sensitivity and specificity of the routine care strategy.

All patients are recruited during the pre-anaesthesia visit by an anaesthesiologist, in different anaesthetic sectors each day of the week, so that different types of surgery are represented.

Each day (from Monday to Friday), the first 2 eligible patients will be offered to take part in the study.

Routine care strategy is not modified by the study protocol. In addition, the simple structured questionnaire will be completed by the patient with a research assistant after the pre-operative consultation As recommended in diagnostic studies, the gold standard (see secondary endpoint paragraph) will be performed consistently in all patients to avoid verification bias.

The improvement of screening for the need of further investigations by use of the questionnaire compared to routine care will be measured counting how many patients are adequately reclassified with the questionnaire compared to the routine care strategy, regarding the gold standard (using the Net Reclassification Index)."

Conditions

  • Pre-operative Haemorrhagic Risk

Interventions

OTHER

questionnaire

assessing the sensitivity and specificity of a simple structured questionnaire

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Dan LONGROIS, Pr · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-25
Primary Completion
2018-12-31
Completion
2019-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02617381 on ClinicalTrials.gov