CVA stroke
Conditions
Interventions
None listed
Sponsors
Gelre Ziekenhuizen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Suffering from ischemic stroke - Indicated treatment with tPA for thrombolysis - Age > 18 years
Exclusion criteria
Exclusion criteria: - Subject presents at the Gelre Hospital Apeldoorn with stroke but send to another hospital for mechanic thrombectomy (endovascular recanalization therapy) - Stroke onset was more than 4.5 hours ago at the time of presentation at the Gelre Hospital. This precludes treatment with tPA, according to clinical practice guidelines, independent of the study protocol. - Previously documented coagulation defects - Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An inventory of possible problems occurring for each of the study aspects a-d specified under **Objectives** will be made and evaluated during and at the end of the study, leading to a **go** or **no go** decision for a larger follow up study. A **no go** decision will be made if problems that potentially jeopardize the entire study could not be solved/are recurring during the pilot study. This will be objectified by the following items that we will include in our inventory: a) - Patients fulfil inclusion criteria but are **missed** for inclusion in the study (not asked by investigator, this does not include patients who do not want to participate). - Patients are included that should not have been included as they fulfil (one of the) exclusion criteria. - Complaints/questions about unclarity of inclusion/exclusion criteria received by investigator(s). - Transportation to/arrival at the laboratory >2 hours after blood drawal - Mistakes in informed consent procedure, such as wrong forms were given to patient or representative, signed forms missing/not stored properly, no notification of investigator at the lab of inclusion patient - Mistakes in blood drawal, for example in type and number of extra tubes drawn. - Clinical scores are not obtained/reported by investigators. b) Complaints from patients/representatives about e.g. lengthiness, language used (not layman enough). c) Partially overlapping with a (e.g. mistakes in blood drawing, logistics, inclusion of patients), but also including: mistakes in technical handling and processing of blood samples at the laboratory, performing tests, aliquoting and freezing plasma for later use, administration of included patients, test results, sample storage. Inventory will be made. d) Equipment refers to all materials and apparatus used for the laboratory tests, including the fluorometer for plasmin generation and thrombin generation, the flow cytometer for platelet function testing, the STA-R Evo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary laboratory parameters are: - Directly related to plasmin: o Clot lysis turbidity assay o Plasminogen o tPA o PAI-1 o von Willebrand factor and activated von Willebrand factor o Fibrinogen o Plasmin-anti-plasmin (PAP) - Not directly related to plasmin o Platelet function test * Platelet Activation Test (PACT) o D-dimer o Thrombin generation (0, 1, 5 pM, 5pM+TM; before tPA and 48 hours after tPA treatment) Also, several clinical data will be collected in this study: Patient related - Date of birth (age) - Ethnicity - Gender - Body weight (kg) 1 - Length (cm) - BMI (obesity) Therapy related - Time to tPA treatment from arrival at the hospital - Comedication (a.o. thrombocyte aggregation inhibitors, DOACs, other anticoagulants) and duration of these medications. - Dose of tPA (weight based) - Surgery - Occurrence of an allergic reaction to tPA (very rare) Disease related - Stroke severity score NIHSS 2 - modified Rankin Scale (mRS) - Prior history of thrombosis - Prolonged immobility - Comorbidities - Type of bleeding if it occurs (e.g. epistaxis, intracerebral) - Type of recurrent thrombosis if it occurs - Mortality at 90 days | — |
Countries
Netherlands
Outcome results
None listed