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

NCT02617381 | Completed

• 1 other identifier: K140901
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Simple structured questionnaire

  To estimate the diagnostic accuracy (specificity, sensibility and likelihood ratios) of a simple structured questionnaire at the pre-anaesthesia visit, to identify patients requiring further haemostatic investigations for haemorrhagic risk (HgR) assessment as defined by the gold standard (a full haemostatic investigation), i.e. patients for whom further haemostatic investigations would conclude to an increase haemorrhagic risk.

  3 months

Secondary Outcomes (1)

• Use of the Net Reclassification Improvement Index (NRI)

  3 months

Study Arms (1)

questionnaire

EXPERIMENTAL

assessing the sensitivity and specificity of a simple structured questionnaire

Other: questionnaire

Interventions

questionnaire OTHER

assessing the sensitivity and specificity of a simple structured questionnaire

questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients seen at the pre-anaesthesia visit by an anaesthesiologist before any scheduled intervention (except for cardiac, vascular, hepatic, obstetrical surgery, since these procedures are associated with a high HgR; neurosurgery is also excluded, due to fatal or functional consequences in case of small volume blood loss).
• Age \> 18 years
• Signed informed consent

You may not qualify if:

• Patients under long term antiplatelet and/or anticoagulant therapy
• Not French speaker
• Not affiliated to any social security covering

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Bichat-Claude Bernard

Paris, 75018, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Dan LONGROIS, Pr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 1, 2015
• Study Start: January 25, 2016
• Primary Completion: December 1, 2018
• Study Completion: August 1, 2019
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

FR (1)