Pre-operative Haemorrhagic RiskHEMORISQNCT02617381
Pre-operative Haemorrhagic Risk Screening, Using a Standardized Questionnaire Before Scheduled Surgeries
A study testing questionnaire in people with Pre-operative Haemorrhagic Risk, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-operative Haemorrhagic Risk
- What is being tested?
- questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2016to Aug 2019
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- Patients under long term antiplatelet and/or anticoagulant therapy
- Not French speaker
- Not affiliated to any social security covering
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-operative Haemorrhagic Risk Screening, Using a Standardized Questionnaire Before Scheduled Surgeries.
"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.
Read more
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)."
Read the detailed description
"Screening for the need of an extensive haematological investigation in order to determine the existence of inherited or acquired haemostatic abnormalities at the pre-anaesthesia visit is part of a routinely used strategy to prevent perioperative haemorrhagic complications. In France, this screening is mainly based on a basic set of haemostatic tests: prothrombin time (PT), activated partial thromboplastin time (aPTT) and platelet count (PC). When these tests are abnormal, the patient may undergo a more complete set of haemostatic tests and, if needed, be referred to a haematologist for advice. Nevertheless, all published studies have pointed out the scarce efficacy of preoperative PT/aPTT/PC testing for hemorrhagic risk assessment.
Therefore, in 2011 several professional societies have advised AGAINST using this strategy and advocated its replacement by a structured questionnaire for the screening of the need of further haemostatic investigations (to validate or not an increased risk of perioperative haemorrhage). Nevertheless, the performance of a screening strategy relying on such a structured questionnaire has never been studied in the pre-anaesthesia context. This probably explains why many anaesthesiologists still continue to prescribe PT/aPTT/PC to detect haemostatic abnormalities and don't use any questionnaire.
Thus, our hypothesis is that a validated structured and simple questionnaire is an accurate screening strategy to determine patients requiring further haemostatic investigations in the preoperative setting.
One of the main reasons for the non compliance with the guidance advising against the use of screening haemostatic tests (PT/aPTT/PC) for the identification of patients with potential haemorrhagic risk is probably related to the fact that the alternative strategy proposed to anaesthesiologists (the use of a structured questionnaire) has never been investigated before in the context of the pre-anaesthesia visit. Therefore, the present project would estimate the diagnostic performance (sensitivity and specificity) of a simple structured questionnaire to identify patients requiring further haemostatic investigations (i.e. patients for whom further haemostatic investigations would conclude to an increase haemorrhagic risk). The innovative approach of the project is related to: (i) the choice of a simple structured questionnaire, specifically conceived to be used at the pre-anaesthesia visit; (ii) a study design that takes into account the needs of the final users (the anaesthesiologist and the surgical team).
To estimate the diagnostic accuracy of a questionnaire at the pre-anaesthesia visit, to identify patients requiring further haemostatic investigations for haemorrhagic risk assessment as defined by a full haemostatic investigation (i.e. patients for whom full haemostatic investigations would conclude to an increase haemorrhagic risk)
- To estimate the diagnostic accuracy (specificity, sensibility and likelihood ratios) of the current routine care strategy at the pre-anaesthesia visit (i.e. no structured questionnaire, and prescription of further haematological tests at the sole discretion of the anaesthesiologist) to identify patients requiring further haemostatic investigations for HgR as defined by the gold standard (a full haemostatic investigation).
- To measure the improvement in the identification of patients requiring further haemostatic investigations for HgR assessment using a simple structured questionnaire, compared to usual care, in pre-operative patients (i.e. to describe how many patients are adequately reclassified by using the questionnaire).
- To describe how many patients had a major peri-operative bleeding event with respect to the answers to the simple structured questionnaire."
- Conditions
- Pre-operative Haemorrhagic Risk
- Being tested
- questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
assessing the sensitivity and specificity of a simple structured questionnaire
| Study group | Role | What they receive |
|---|---|---|
| questionnaire | Experimental | assessing the sensitivity and specificity of a simple structured questionnaire Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Use of the Net Reclassification Improvement Index (NRI)
The diagnostic classification provided by the strategy based on the questionnaire compared to that based on hemostasis screening tests will be evaluated by Net Reclassification Improvement Index (NRI)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start25 Jan 2016
- Primary completionDec 2018
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-operative Haemorrhagic RiskStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan LONGROIS, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617381
- Sponsor's protocol ID
- K140901
- Acronym
- HEMORISQ
- Status last verified
- Mar 2020
- First submitted
- 19 Nov 2015
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Haemorrhagic Risk Screening, Using a Standardized Questionnaire Before Scheduled Surgeries.
- ClinicalTrials.gov ID
- NCT02617381
- Acronym / sponsor ID
- HEMORISQ / K140901
- Conditions
- Pre-operative Haemorrhagic Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 1 Dec 2015 (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.
"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)."
Detailed description
"Screening for the need of an extensive haematological investigation in order to determine the existence of inherited or acquired haemostatic abnormalities at the pre-anaesthesia visit is part of a routinely used strategy to prevent perioperative haemorrhagic complications. In France, this screening is mainly based on a basic set of haemostatic tests: prothrombin time (PT), activated partial thromboplastin time (aPTT) and platelet count (PC). When these tests are abnormal, the patient may undergo a more complete set of haemostatic tests and, if needed, be referred to a haematologist for advice. Nevertheless, all published studies have pointed out the scarce efficacy of preoperative PT/aPTT/PC testing for hemorrhagic risk assessment.
Therefore, in 2011 several professional societies have advised AGAINST using this strategy and advocated its replacement by a structured questionnaire for the screening of the need of further haemostatic investigations (to validate or not an increased risk of perioperative haemorrhage). Nevertheless, the performance of a screening strategy relying on such a structured questionnaire has never been studied in the pre-anaesthesia context. This probably explains why many anaesthesiologists still continue to prescribe PT/aPTT/PC to detect haemostatic abnormalities and don't use any questionnaire.
Thus, our hypothesis is that a validated structured and simple questionnaire is an accurate screening strategy to determine patients requiring further haemostatic investigations in the preoperative setting.
One of the main reasons for the non compliance with the guidance advising against the use of screening haemostatic tests (PT/aPTT/PC) for the identification of patients with potential haemorrhagic risk is probably related to the fact that the alternative strategy proposed to anaesthesiologists (the use of a structured questionnaire) has never been investigated before in the context of the pre-anaesthesia visit. Therefore, the present project would estimate the diagnostic performance (sensitivity and specificity) of a simple structured questionnaire to identify patients requiring further haemostatic investigations (i.e. patients for whom further haemostatic investigations would conclude to an increase haemorrhagic risk). The innovative approach of the project is related to: (i) the choice of a simple structured questionnaire, specifically conceived to be used at the pre-anaesthesia visit; (ii) a study design that takes into account the needs of the final users (the anaesthesiologist and the surgical team).
To estimate the diagnostic accuracy of a questionnaire at the pre-anaesthesia visit, to identify patients requiring further haemostatic investigations for haemorrhagic risk assessment as defined by a full haemostatic investigation (i.e. patients for whom full haemostatic investigations would conclude to an increase haemorrhagic risk)
- To estimate the diagnostic accuracy (specificity, sensibility and likelihood ratios) of the current routine care strategy at the pre-anaesthesia visit (i.e. no structured questionnaire, and prescription of further haematological tests at the sole discretion of the anaesthesiologist) to identify patients requiring further haemostatic investigations for HgR as defined by the gold standard (a full haemostatic investigation).
- To measure the improvement in the identification of patients requiring further haemostatic investigations for HgR assessment using a simple structured questionnaire, compared to usual care, in pre-operative patients (i.e. to describe how many patients are adequately reclassified by using the questionnaire).
- To describe how many patients had a major peri-operative bleeding event with respect to the answers to the simple structured questionnaire."
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionnaire | Experimental | Other: questionnaireassessing the sensitivity and specificity of a simple structured questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients under long term antiplatelet and/or anticoagulant therapy
- Not French speaker
- Not affiliated to any social security covering
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireassessing the sensitivity and specificity of a simple structured questionnaire | Other | questionnaire |
Primary outcome
Simple structured questionnaire
Time frame: 3 months
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.
1 secondary outcome
Use of the Net Reclassification Improvement Index (NRI)
Time frame: 3 months
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 12 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Pre-operative Haemorrhagic Risk
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.
Dan LONGROIS, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire in people with Pre-operative Haemorrhagic Risk, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 3 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 12 Mar 2020. 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?
Simple structured questionnaire (time frame: 3 months). 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 12 Mar 2020.