PrEdict: Systematic Analysis of a Standardized Questionnaire to Detect Possible Bleeding Disorders and Its Impact on Perioperative Hemostasis Management
Study Details
Study Description
Brief 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. 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.
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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
Outcome Measures
Primary Outcome Measures
- Relative frequency of changes in the initially planned perioperative procedure [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
Secondary Outcome Measures
- Perioperative complications [Perioperative period]
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)
- Diagnostic discrepancy [Perioperative period]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
All adult (age ≥ 18 years) patients of both genders undergoing elective surgery at the Benjamin Franklin campus in the 12-month period
Exclusion Criteria:
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Pregnancy, lactation
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Patients not capable of giving consent
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Already diagnosed hemostasis disorder
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Patients under (plasmatic) anticoagulation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin | Berlin | Germany | 12203 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
- Institute for biometry and clinical epidemiology, Charité University Berlin, Germany
- Institute for transfusion medicine, Charité University Berlin, Germany
- Einstein center digital future
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EA4/181/20