Safety and Efficacy of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke
Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
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 onset of clinical signs. Overall administration of anticoagulant agents will test
72 hours.
Randomized patients will be divided into three groups. The first group of patients will
receive heparin intravenously at the beginning of 2500 UI bolus intravenously, followed by
intravenous pump 1000 UI / h (18-20 IU / kg / hr) to reach 2-2.5 times the baseline aPTT.
After 24 hours, patients will receive the group Nadroparin subcutaneously in the therapeutic
dose.
Second group of patients will be administered subcutaneously Nadroparin the therapeutic dose
as recommended.
The third group of patients are those who will receive placebo intravenously and 24 hours
after receiving nadroparin subcutaneously in the therapeutic dose.
All patients will receive after 24 hours of starting treatment 100 mg of aspirin per orally.
For initiation of treatment will be assessed:
- Modified Rankin Scale, National Institutes of Health Stroke Scale, inclusion, exclusion
criteria
- Sign the informed consent and patient randomization
- Laboratory parameters: glucose, creatinine, GGT, K, Na, Cl, blood count, basic
coagulation
- Women of childbearing age (pregnancy test)
- History, clinical presentation, medical history, basic internal review of the status
(blood pressure, pulse, body temperature, etc.).
- Initial CT examination of the brain
- EKG
- USG sections of extracranial carotid and vertebral arteries
- special hematology factors
If a patient meets all the necessary criteria, he may be given the test substance. During the
first 24 hours will be monitored at regular intervals vital functions.
After 24 hours, each patient received subcutaneous Nadroparin the therapeutic dose and also
100 mg of aspirin per orally.
In the interval from 24 to 30 hours of starting treatment the patient will be made:
- Control CT brain
- EKG
- Basic coagulation
- Reduction to stop treatment for newly identified haemorrhage or severe and extensive
focal cerebral ischemia by CT scan
- special hematology factors
72 hours, 7, 30 and 90 days after starting treatment, the patient's clinical evaluation
using the Modified Rankin Scale, National Institutes of Health Stroke Scale and Barthel
Index.
Safety endpoints: mortality, adverse side effects, bleeding