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Transcranial doppler And CTangiography for Investigating Cerebral vasospasm in Subarachnoid hemorrhage study


- candidate number15357
- NTR NumberNTR4157
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-sep-2013
- Secondary IDsNL41458.041.12 
- Public TitleTranscranial doppler And CTangiography for Investigating Cerebral vasospasm in Subarachnoid hemorrhage study
- Scientific TitleTranscranial doppler And CTangiography for Investigating Cerebral vasospasm in Subarachnoid hemorrhage
- ACRONYMTACTICS
- hypothesisComparison of CT-angiography and Transcranial doppler for the detection of cerebral vasospasm after aneurysmal subarachnoid hemorrhage
- Healt Condition(s) or Problem(s) studiedSubarachnoid hemorrhage (SAH), Cerebral blood flow
- Inclusion criteriaAneurysmal subarachnoid hemorrhage
Age 18 years or older
Inclusion within 4 days after onset
Written informed consent
- Exclusion criteriaVery poor prognosis
Renal insufficiency (eGFR < 60 ml/min/1.73m2)
Treatment with metformine
Inability to perform TCD (temporal bone window)
Contraindication for iodinated contrast agent (allergy, m. Kahler, myasthenia gravis, pheochromocytoma, mastocytosis, thyroid cancer, nuclear thyroid scan)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 4-sep-2013
- planned closingdate1-dec-2014
- Target number of participants60
- InterventionsComparison of CT angiography and Transcranial doppler in the detection of cerebral vasospasm after subarachnoid hemorrhage.
- Primary outcomeSensitivity and specificity.
- Secondary outcomePrediction of clinically relevant vasospasm.
- TimepointsTCD 3 times a week
CTA on day 5 and 10 (+/- 1 day)
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M. Uyttenboogaart
- CONTACT for SCIENTIFIC QUERIESDr. M. Uyttenboogaart
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsThe results of this pilot study will be published in an international peer reviewed journal.
- Brief summaryThis study is an observation pilot study in which prospectively consecutive patients with a subarachnoid hemorrhage are included. All patients are screened with TCD 2-3 times a week for vasospasm, according to the local management guidelines. Besides TCD, a CT-A scans are made for each patient on day 5 and 10 and in case of clinical deterioration. The results of TCD and CTA are compared and linked to clinical symptoms. In case of clinically symptomatic vasospasm, patients are treated according to a pre-defined protocol which is documenten in the local management guidelines. After finishing the pilot studies, we are planning to set-up a large scale cost-effectiveness study in order to investigate which method is most efficient.
- Main changes (audit trail)
- RECORD3-sep-2013 - 12-okt-2013


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