Status:
UNKNOWN
Safety and Efficacy of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke
Lead Sponsor:
University Hospital, Martin
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The goal of this study is to show the efficacy and safety of heparin and nadroparin in the acute phase of ischemic stroke. Therapeutic agents are administered at intervals of 4.5 to 2 hours after onse...
Eligibility Criteria
Inclusion
- ischemic stroke
- female or male gender
- mRS (modified Rankin Scale) 0-1 (min one month before the event)
- NIHSS ≥ 6 and ≤ 25
- Age: 18-80 years
- initiation of therapy in the interval from 4.5 to 24 hours from onset of symptoms of ischemic stroke
- focal neurological deficit of at least 30 min, which was significantly obviously does not disappear before treatment
- patient will participate voluntarily and signed informed consent. Informed consent will be obtained from each patient, guardian or close relative
- patients who are unable to sign, but who are able to understand what means to participate in the study, may give informed consent through eyewitness
- willingness and ability to comply with the protocol
Exclusion
- intracranial hemorrhage confirmed by CT scan
- CT image heavy and extensive focal cerebral ischemia
- lacunar syndrome
- epileptic seizure at the beginning of ischemic stroke
- previous or planned treatment with intravenous, intra-arterial thrombolysis, mechanical recanalization or ultrasound assisted thrombolysis
- stroke, myocardial infarction, head trauma in the last 3 months
- tromboctov count below 100 000/mm ³
- therapeutically uncontrolled blood pressure: systolic blood pressure\> 185 mmHg or diastolic blood pressure\> 110 mmHg
- therapeutically uncontrolled blood glucose ˂ 2.77 or\> 22.15 mmol / l
- Known bleeding diathesis, other coagulopathies, severe hepatopathy, severe nephropathy
- patients receiving oral anticoagulants
- current or previous life-threatening bleeding
- major surgery less than 2 weeks ago
- known malignancy
- active TB
- pregnancy
- allergy to Heparin or Fraxiparine
- known alcohol abuse and / or drugs
- active participation in another clinical study
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01862978
Start Date
May 1 2013
End Date
December 1 2015
Last Update
August 15 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Neurology Clinic Univeristy Hospital in Martin
Martin, Slovakia, 03659