Verification of preoperative screening for bleeding tendency in patients that report bleeding symptoms

Completed

• Conditions: hemorrhagic diathesis; bleeding tendency; 10064477; 10005330; 10047075

• Registration Number: NL-OMON40106
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-06-30
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 439

Inclusion Criteria

Study group:
Adult subjects (at least 18 years of age) with planned elective surgery
Patient has provided informed consent
Subject has marked at least one question positively on the preoperative screening list for bleeding tendency;Control group:
Adult subjects (at least 18 years of age) with planned elective surgery
Patient has provided informed consent
Subject has marked no questions positively on the preoperative screening list for bleeding tendency
(Add to D2; these controls are 'healthy' in the sense 'no bleeding disorder')

Exclusion Criteria

For both the study group and control group:
Incapacitated subjects
Subjects referred to the hematology department preoperatively for consultation
Known blood clotting disease (haemophilia, Von Willebrand disease or other)
Use of thrombocyte aggregation inhibitors, NSAID*s or anticoagulants (i.e. prohibited medication)
Known thrombocyte level lower than 150,000/µl
Known hematocrit lower than 35%

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Diagnostic parameters, such as sensitivity and specificity of the new study<br /><br>package when compared to the gold standard package in bleeding tendency<br /><br>diagnosis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The predictive value of a bleeding risk score for presence of a bleeding<br /><br>disorder (according to the gold standard package) expressed as the area under<br /><br>the curve (AUC) of the receiver operating characteristic (ROC) curve.<br /><br><br /><br>Sensitivity and specificity estimates at different cut-off points of the<br /><br>bleeding risk score and corresponding percentages of patients undergoing more<br /><br>elaborate screening.<br /><br><br /><br>Results of tests aimed at detection of bleeding disorders (study package,<br /><br>consisting of point-of-care tests and genetic tests, see par 4.4 in research<br /><br>protocol) and bleeding risk score. Determine reference values of these tests<br /><br>for a pre-operative group, using a control group.<br /><br><br /><br>Use of blood products during a follow-up of 30 months after surgery. </p><br>