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ID
23150
Beschreibung
Responsible Party: Susanne Bonekamp, Prof. Dr. Martin Bendszus, University Hospital Heidelberg ClinicalTrials.gov Identifier: NCT02135926 History of Changes Other Study ID Numbers: UH-Heidelberg-THRILL DRKS00005792 ( Registry Identifier: Deutsches Register Klinischer Studien ) Study First Received: April 30, 2014 Last Updated: February 15, 2017 Comparison of Thrombectomy and Standard Care for Ischemic Stroke in Patients Ineligibility for Tissue Plasminogen Activator Treatment (THRILL) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02135926
Link
https://clinicaltrials.gov/ct2/show/NCT02135926
Stichworte
Versionen (2)
- 26.06.17 26.06.17 -
- 20.09.21 20.09.21 -
Hochgeladen am
26. Juni 2017
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibilty Thrombectomy for Ischemic Stroke DRKS00005792 NCT02135926 DRKS00005792
Eligibilty Thrombectomy for Ischemic Stroke NCT02135926 DRKS00005792
Ähnliche Modelle
Eligibilty Thrombectomy for Ischemic Stroke NCT02135926 DRKS00005792
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Ineligible for tPA treatment
Item
Patient is ineligible for treatment with IV tPA according to licensing criteria (e.g. anticoagulation, previous surgery, or beyond 4.5 hours after symptom onset).
boolean
C0749606 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,2])
Randomization: Time of Onset
Item
Randomization within 7 hours after stroke onset.
boolean
C0034656 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,2])
Thrombectomy
Item
Endovascular treatment is expected to be finished within 8 hours after symptom onset by judgment of the interventional Neuroradiologist in charge.
boolean
C0162578 (UMLS CUI [1])
Symptoms of an Ischemic Stroke
Item
Patient must demonstrate clinical signs and symptoms attributable to target area of occlusion consistent with the diagnosis of ischemic stroke, including impairment of the following: language, motor function, sensation, cognition, gaze, and/or vision for at least 30 minutes without relevant improvement.
boolean
C1457887 (UMLS CUI [1,1])
C0948008 (UMLS CUI [1,2])
C0948008 (UMLS CUI [1,2])
Age
Item
Female and male patient between 18-80 years of age
boolean
C0001779 (UMLS CUI [1])
NIHSS Score
Item
NIHSS Score of >7 and <25
boolean
C3476804 (UMLS CUI [1])
Informed Consent
Item
Patient signed informed consent (IC) form by patient, legal representative, or by an independent physician who is familiar with this types of illness if the other options are not possible.
boolean
C0021430 (UMLS CUI [1])
Neuroradiology: Site of Lesion
Item
A new focal occlusion confirmed by imaging (MRA/CTA) to be accessible to the thrombectomy device, and located in the M1 of the middle cerebral artery (MCA) and/or the intracranial segment of the distal internal carotid artery (ICA).
boolean
C2183225 (UMLS CUI [1,1])
C0449685 (UMLS CUI [1,2])
C0449685 (UMLS CUI [1,2])
Modified Rankin Scale Score
Item
Prior to new focal neurological deficit, mRS score was ≤1.
boolean
C3828944 (UMLS CUI [1])
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
tPA Treatment
Item
Patient is eligible for and receives IV tPA according to licensing criteria
boolean
C0749606 (UMLS CUI [1])
INR
Item
Patient with an international normalized ratio (INR) of >3
boolean
C0525032 (UMLS CUI [1])
Study Participation Status
Item
Patient is an active participant in another drug or device treatment trial for any disease state, or patient is expected to start participation in another drug or device treatment trial while enrolled in this protocol, unless approved by Sponsor.
boolean
C2348568 (UMLS CUI [1])
Neurological or psychatric disease
Item
Patient has pre-existing neurological or psychiatric disease that could impede the study results or would confound the neurological or functional evaluations.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0004936 (UMLS CUI [2])
Carotid dissection or stenosis
Item
Patient has carotid dissection, high grade stenosis ≥ 70% proximal to occlusion that requires stenting, or excessive tortuosity to gain access to occlusion, as determined by MRA/ CTA of neck and head.
boolean
C0338585 (UMLS CUI [1])
C0007282 (UMLS CUI [2])
C0007282 (UMLS CUI [2])
Vascular disease
Item
Patient has vascular disease preventing endovascular treatment (e.g. aortic dissection or aneurysm, no arterial transfemoral access)
boolean
C0042373 (UMLS CUI [1])
Contraindication for Contrast medium
Item
Patient has history of contraindication for contrast medium.
boolean
C0009924 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,2])
Infective endocarditis
Item
Patient is known to have infective endocarditis
boolean
C1541923 (UMLS CUI [1])
Neuroradiology finding
Item
CT scan or MRI with evidence of: Mass effect or intracranial tumor, or hypodensity on unenhanced CT and cerebral blood volume (CBV) drop on CBV maps on Computed Tomography Perfusion (CTP), or, alternatively as per institutional standard, restricted diffusion on Diffusion weighted imaging (DWI) with an Alberta Stroke Program Early CT score (ASPECTs) of 6 or less
boolean
C2183225 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
Gynaecological Status
Item
Female of childbearing potential who is known to be pregnant and/or lactating or who has a positive pregnancy test on admission.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Life expectancy
Item
Patient‟s anticipated life expectancy is less than 6 Months.
boolean
C0023671 (UMLS CUI [1])