The Clinical Relevance and Significance of New Diagnostic Options in patients with unexplained bleeding

The Clinical Relevance and Significance of New Diagnostic Options in patients with unexplained bleeding - The CRESCENDO-study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45968

Enrollment

330

Registered

2016-06-21

Start date

2016-07-20

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

bleeding disorder unexplained bleeding tendency

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients of all ages; Patients with a significant history of bleeding tendency according to physician opinion or abnormal bleeding score based on a BAT o with no defined diagnosis after routine testing (see appendix 4 of the research protocol), o with a heterozygous factor deficiency or low Von Willebrand Factor levels that do not correspond with the experienced bleeding tendency, o with aberrant laboratory results not fitting a diagnosis; Informed consent should be provided prior to any study specific procedure.

Exclusion criteria

Exclusion criteria: Patients with a defined bleeding disorder after routine testing (see appendix 4 of the research protocol, except when they serve as controls for the trombocytopathy arm); Patients under therapy with anticoagulants and / or antiplatelet and / or anti-inflammatory agents whom cannot stop their medication during the diagnostic work-up; Patients with thrombocytopenia

Design outcomes

Primary

Measure	Time frame
To determine the association between the bleeding phenotype (based on medical history and / or bleeding score), new diagnostic tests and bleeding complications during a one year follow-up period.	—

Secondary

Measure	Time frame
The (number of) abnormalities identified or localised (platelet related, primary or secondary hemostasis, fibrinolysis) in the individual patients coagulation potential based on new diagnostic tools. These abnormalities can be: o Abnormalities in ROTEM® pattern o Abnormalities in thrombin generation pattern o Abnormalities in clot lysis pattern o Combined abnormalities in global hemostatic assays o Abnormalities in platelet proteomics o Abnormalities on electron microscopy o Abnormalities on flowcytometry o Abnormalities in megakaryocyte development o Novel DNA mutations o Secondary abnormalities in patients with low VWF-levels o Secondary abnormalities in patients with heterozygous factor deficiencies o Abnormalities in fibrinolytic activators or inhibitors Evaluation of treatment advice during two years follow-up, by means of: o Type of bleeding symptoms o Frequency of bleeding symptoms o Treatment advice given in patients with unexplained bleeding o Treatment advice followed during (dental) surgical procedures or after trauma o Management of bleeding: Local treatment, Antifibrinolytic agents or DDAVP, Transfusion of red blood cells (RBC), platelets, plasma, PCC or other factor concentrates, Surgical, endoscopic or radiologic interventions to control bleeding o Thromboemolic complications within 30 days after treatment of bleeding Most optimal timing of diagnostic evaluation in premenopausal women with unexplained bleeding based on the cyclic variation of hemostatic variables.	—

Measure

Time frame

The (number of) abnormalities identified or localised (platelet related, primary or secondary hemostasis, fibrinolysis) in the individual patients coagulation potential based on new diagnostic tools. These abnormalities can be: o Abnormalities in ROTEM® pattern o Abnormalities in thrombin generation pattern o Abnormalities in clot lysis pattern o Combined abnormalities in global hemostatic assays o Abnormalities in platelet proteomics o Abnormalities on electron microscopy o Abnormalities on flowcytometry o Abnormalities in megakaryocyte development o Novel DNA mutations o Secondary abnormalities in patients with low VWF-levels o Secondary abnormalities in patients with heterozygous factor deficiencies o Abnormalities in fibrinolytic activators or inhibitors Evaluation of treatment advice during two years follow-up, by means of: o Type of bleeding symptoms o Frequency of bleeding symptoms o Treatment advice given in patients with unexplained bleeding o Treatment advice followed during (dental) surgical procedures or after trauma o Management of bleeding: Local treatment, Antifibrinolytic agents or DDAVP, Transfusion of red blood cells (RBC), platelets, plasma, PCC or other factor concentrates, Surgical, endoscopic or radiologic interventions to control bleeding o Thromboemolic complications within 30 days after treatment of bleeding Most optimal timing of diagnostic evaluation in premenopausal women with unexplained bleeding based on the cyclic variation of hemostatic variables.

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Countries

Netherlands

Outcome results