Ignite Creation Date:
2024-05-06 @ 1:39 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01862978
Status:
UNKNOWN
Last Update Posted:
2013-08-15
First Post:
2013-05-20
Brief Title:
Safety and Efficacy of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke
Sponsor:
University Hospital Martin
Organization:
University Hospital Martin
Study Overview
Official Title:
Monitoring the Efficacy and Safety of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke
Status:
UNKNOWN
Status Verified Date:
2013-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Heparinas
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 45 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 2-25 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 patients clinical evaluation using the Modified Rankin Scale National Institutes of Health Stroke Scale and Barthel Index
Safety endpoints mortality adverse side effects bleeding
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 2-25 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 patients clinical evaluation using the Modified Rankin Scale National Institutes of Health Stroke Scale and Barthel Index
Safety endpoints mortality adverse side effects bleeding
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None