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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40106

Enrollment

870

Registered

2012-04-04

Start date

2013-08-26

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemorrhagic diathesis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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%

Design outcomes

Primary

Measure	Time frame
Diagnostic parameters, such as sensitivity and specificity of the new study package when compared to the gold standard package in bleeding tendency diagnosis.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results