The purpose of this project is to determine the impact of pretreatment fibrinogen gamma*/ total fibrinogen ratios on the success of rtPA therapy.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Neurological improvement by means of the NIHSS at 24 hours and discharge.
Secondary outcome
The extent of fibrinogen breakdown measured by markers of fibrinolysis (such as
plasma D-dimer concentrations).
Background summary
Intravenous thrombolysis using recombinant tissue plasminogen activator (rtPA)
is still the only approved therapy for acute ischemic stroke. Although
thrombolytic therapy significantly improves outcome after ischemic stroke,
blood supply is not restored in a large proportion of patients, because rtPA
infusion does not effectively lyse the clot. A fibrinogen variant, fibrinogen
gamma* has prothrombotic properties by increasing the rate of factor XIII
activation resulting in denser clot conformation.
Study objective
The purpose of this project is to determine the impact of pretreatment
fibrinogen gamma*/ total fibrinogen ratios on the success of rtPA therapy.
Study design
Patients with ischemic stroke, treated with rtPA, will be prospectively
studied. All patients will receive computed tomography (CT) scan and computed
angiography (CTA) scan at admission and a CT-scan at day 3. Blood samples will
be obtained before rtPA treatment and at hours 3, 24 hours and at day 3 after
initiation of therapy to determine total fibrinogen, gamma* *fibrinogen and
plasma D-concentrations.
Study burden and risks
4 times vena punction for collection of blood.
CT on day 3 (2.1-2.3mSv)
's Gravendijkwal 230
3015 CE Rotterdam
NL
's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
-a clinical diagnosis of acute ischaemic stroke
- a measurable deficit on the NIHSS or NIHSS supplemental motor score
- treatment with intravenous or intra-arterial alteplase
Exclusion criteria
contra-indications for treatment with iv or ia rt-PA, i.e.
-cerebral infarction within the previous 6 weeks,
-a history of intracerebral hemorrhage,
-severe head injury the previous 4 weeks,
-major surgery, gastrointestinal bleeding or urinary tract bleeding within the previous 2 weeks
-arterial blood pressure > 185/110 mmHg,
-blood glucose < 2.7 or > 22.2 mmol/l,
-clinical signs of hemorrhagic diathesis or platelet count <90 x 10*9/L, APTT>50 sec or INR >1.7.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30811.078.09 |