Perioperative HemorrhagePrEdictNCT04993170
Systematic Analysis of a Standardized Questionnaire to Detect Possible Bleeding Disorders and Its Impact on Perioperative Hemostasis Management
An observational study of Perioperative Hemorrhage and Hemostasis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
With the help of a standardized questionnaire, an increased risk of bleeding due to pre-existing hemostasis disorders in the site-specific patient population will be detected and the corresponding enhanced diagnostic measures will be initiated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Hemorrhage, Hemostasis
- What is being tested?
- Bleeding assessment tool
- How many people
- 5,004 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jun 2021to 1 Jun 2024
- 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: All adult (age ≥ 18 years) patients of both sexes undergoing elective surgery at the Benjamin Franklin Campus in the period of 12 months and presenting at the anesthesiological preoperative assessment will be recorded. A historical cohort that received surgical care at the Benjamin Franklin campus prior to the introduction of the questionnaire (07/01/2018 - 06/30/2019) will serve as the comparison group.
Who may be able to join
- All adult (age ≥ 18 years) patients of both genders undergoing elective surgery at the Benjamin Franklin campus in the 12-month period
Who cannot join
- Pregnancy, lactation
- Patients not capable of giving consent
- Already diagnosed hemostasis disorder
- Patients under (plasmatic) anticoagulation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 12203
About this study
Official title: Systematic Analysis of a Standardized Questionnaire to Detect Possible Bleeding Disorders Used in Clinical Routine During Anaesthesiological Preoperative Assessment and Its Impact on Perioperative Hemostasis Management
With the help of a standardized questionnaire, an increased risk of bleeding due to pre-existing hemostasis disorders in the site-specific patient population will be detected and the corresponding enhanced diagnostic measures will be initiated. The planned prospective observational study should i.) systematically investigate the results of this procedure and ii.) allow a comparison with a retrospective perioperative cohort that was cared for at the Benjamin Franklin Campus before the introduction of the questionnaire. Due to the campus structure with a large vascular surgery center as well as a large urological, general and trauma surgery department, a high number of multimorbid patients with pre-existing disorders of primary hemostasis, mainly caused by medication or secondary diseases, is to be expected.
In the following, the feasibility of the required measures in clinical routine (measured by the frequency of actual changes or modifications of the initially planned perioperative procedure, the adequate implementation of indicated diagnostic measures, etc.) will be examined.
Read the detailed description
The aim of the study is the systematic scientific evaluation of a standardized questionnaire for bleeding history already used in clinical routine during the preoperative anesthesiological visit and its impact on perioperative coagulation management.
The routine use of a standardized questionnaire to assess bleeding risk is based on a study on the preoperative identification of patients with (primary) hemostasis disorders from 2007: in a patient collective of 5649 patients from different disciplines at the Charité - Universitätsmedizin Berlin, a positive predictive value of 99% for the presence of a hemostasis disorder could be established if at least four questions of a standardized bleeding history questionnaire were answered positively. This is not possible in the same way with the plasmatic coagulation-global tests established in clinical routine.
The standardized application of the questionnaire serves to identify patients at risk of bleeding at an early stage and to adapt and optimize perioperative coagulation management accordingly by initiating targeted diagnostics and therapy. However, a systematic scientific evaluation of this questionnaire with regard to the conditions at the Benjamin Franklin Campus with a large vascular surgery center as well as a large urological, general and trauma surgery department and a high number of multimorbid patients with pre-existing disorders of primary hemostasis, mainly caused by medication or secondary diseases, is still pending.
- Conditions
- Perioperative Hemorrhage, Hemostasis
- Being tested
- Bleeding assessment tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleeding assessment toolDiagnostic test
The standardized application of the questionnaire serves to identify patients at risk of bleeding at an early stage and to adapt and optimize perioperative coagulation management accordingly by initiating targeted diagnostics and therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative frequency of changes in the initially planned perioperative procedure
The relative frequency of changes in the initially planned perioperative procedure in patients with abnormalities in the preoperative questionnaire and target-oriented laboratory diagnostics will be measured.
Changes can be:
- need for extended coagulation diagnostics
- hemostaseological consultation preoperatively
- administration of coagulation-active substances
Measured: Perioperative period
Secondary outcomes (2)
Perioperative complications
Compared to a retrospective control group in which no standardized questionnaire was used, the use of a standardized questionnaire and the targeted diagnostics initiated in case of abnormalities lead to
- lower blood loss (estimated in ml, qualitatively)
- a lower transfusion rate during surgery (number of red cell concentrates)
- less time spent in the recovery room (hours:minutes)
- a lower rate of revision surgery due to postoperative bleeding (number of patients)
- fewer organ complications (number of patients, organ failure defined and diagnosed by attending physician)
Measured: Perioperative period
Diagnostic discrepancy
There is a discrepancy between the number of patients, for whom additional diagnostics and measures ,based on the evaluation of the questionnaire,are required on the one hand, and the number ob patients, fo whom these additional diagnostics and measures are actually performed at the time of surgery on the other hand. The relative frequency of these discrepancies should be determined.
Additional diagnostics and measures are:
- extended coagulation diagnostics
- hemostaseological consultation preoperatively
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start23 Jun 2021
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative HemorrhageStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 5,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for biometry and clinical epidemiology, Charité University Berlin, Germany, Institute for transfusion medicine, Charité University Berlin, Germany, Einstein center digital future
- Responsible party
- Principal investigator, Sascha Treskatsch, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993170
- Sponsor's protocol ID
- EA4/181/20
- Acronym
- PrEdict
- Status last verified
- Feb 2025
- First submitted
- 5 Jul 2021
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Analysis of a Standardized Questionnaire to Detect Possible Bleeding Disorders Used in Clinical Routine During Anaesthesiological Preoperative Assessment and Its Impact on Perioperative Hemostasis Management
- ClinicalTrials.gov ID
- NCT04993170
- Acronym / sponsor ID
- PrEdict / EA4/181/20
- Conditions
- Perioperative Hemorrhage, Hemostasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,004 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Institute for biometry and clinical epidemiology, Charité University Berlin, Germany, Institute for transfusion medicine, Charité University Berlin, Germany, Einstein center digital future
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 6 Aug 2021 (actual)
- 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.
With the help of a standardized questionnaire, an increased risk of bleeding due to pre-existing hemostasis disorders in the site-specific patient population will be detected and the corresponding enhanced diagnostic measures will be initiated. The planned prospective observational study should i.) systematically investigate the results of this procedure and ii.) allow a comparison with a retrospective perioperative cohort that was cared for at the Benjamin Franklin Campus before the introduction of the questionnaire. Due to the campus structure with a large vascular surgery center as well as a large urological, general and trauma surgery department, a high number of multimorbid patients with pre-existing disorders of primary hemostasis, mainly caused by medication or secondary diseases, is to be expected.
In the following, the feasibility of the required measures in clinical routine (measured by the frequency of actual changes or modifications of the initially planned perioperative procedure, the adequate implementation of indicated diagnostic measures, etc.) will be examined.
Detailed description
The aim of the study is the systematic scientific evaluation of a standardized questionnaire for bleeding history already used in clinical routine during the preoperative anesthesiological visit and its impact on perioperative coagulation management.
The routine use of a standardized questionnaire to assess bleeding risk is based on a study on the preoperative identification of patients with (primary) hemostasis disorders from 2007: in a patient collective of 5649 patients from different disciplines at the Charité - Universitätsmedizin Berlin, a positive predictive value of 99% for the presence of a hemostasis disorder could be established if at least four questions of a standardized bleeding history questionnaire were answered positively. This is not possible in the same way with the plasmatic coagulation-global tests established in clinical routine.
The standardized application of the questionnaire serves to identify patients at risk of bleeding at an early stage and to adapt and optimize perioperative coagulation management accordingly by initiating targeted diagnostics and therapy. However, a systematic scientific evaluation of this questionnaire with regard to the conditions at the Benjamin Franklin Campus with a large vascular surgery center as well as a large urological, general and trauma surgery department and a high number of multimorbid patients with pre-existing disorders of primary hemostasis, mainly caused by medication or secondary diseases, is still pending.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult (age ≥ 18 years) patients of both sexes undergoing elective surgery at the Benjamin Franklin Campus in the period of 12 months and presenting at the anesthesiological preoperative assessment will be recorded. A historical cohort that received surgical care at the Benjamin Franklin campus prior to the introduction of the questionnaire (07/01/2018 - 06/30/2019) will serve as the comparison group.
Key inclusion criteria (1 listed)
- All adult (age ≥ 18 years) patients of both genders undergoing elective surgery at the Benjamin Franklin campus in the 12-month period
Key exclusion criteria (4 listed)
- Pregnancy, lactation
- Patients not capable of giving consent
- Already diagnosed hemostasis disorder
- Patients under (plasmatic) anticoagulation
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 |
|---|---|---|
| Bleeding assessment toolThe standardized application of the questionnaire serves to identify patients at risk of bleeding at an early stage and to adapt and optimize perioperative coagulation management accordingly by initiating targeted diagnostics and therapy | Diagnostic test | – |
Primary outcome
Relative frequency of changes in the initially planned perioperative procedure
Time frame: Perioperative period
The relative frequency of changes in the initially planned perioperative procedure in patients with abnormalities in the preoperative questionnaire and target-oriented laboratory diagnostics will be measured. Changes can be: * need for extended coagulation diagnostics * hemostaseological consultation preoperatively * administration of coagulation-active substances
2 secondary outcomes
Perioperative complications
Time frame: Perioperative period
Diagnostic discrepancy
Time frame: Perioperative period
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 14 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Perioperative Hemorrhage and Hemostasis, run by Charite University, Berlin, Germany at 1 site in Germany.
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 14 Feb 2025. 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 Germany. 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?
Relative frequency of changes in the initially planned perioperative procedure (time frame: Perioperative period). 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 14 Feb 2025.