Status:
COMPLETED
International Normalized Ratio (INR) Normalization in Coumadin Associated Intracerebral Haemorrhage
Lead Sponsor:
Heidelberg University
Conditions:
Intracranial Hemorrhages
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Intracerebral haemorrhage (ICH) is the most feared complication in patients on vitamin K antagonists (VKA). VKA related ICH occurs 8-10 times more frequently and the mortality is 2 times higher than i...
Eligibility Criteria
Inclusion
- Spontaneous ICH (intraparenchymal), subdural hematoma (SDH) diagnosed by CT scanning ≤ 12 hours after onset of symptoms. In case of unknown time of symptom onset: time between last seen in healthy condition and first CCT ≤ 12 hours.
- Therapy receiving vitamin K antagonists (VKA)
- International Normalized Ratio (INR) ≥ 2
- Signed informed consent form, or signed informed consent by a legal representative, judicial consent in cases where no legal representative is available in time, or consent of an independent physician familiar with the indication in cases where the first three possibilities can not be realized.
Exclusion
- Patients with ICH not related to vitamin-K antagonist therapy or
- Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, hemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma
- Deep Coma (GCS ≤ 5) at the time of admission or before intubation if intubated outside the hospital
- Known previous disability (mRS \> 2 before stroke occurred)
- Acute myocardial ischemia, acute septicemia, acute crush injury, any history of acute hemorrhagic disseminated intravascular coagulation, acute thrombotic stroke
- Known history of intermittent claudication
- Known recent thrombotic event \< 30 days
- Acute or known congestive heart failure (NYHA III, IV)
- Pulmonary edema
- Known liver failure (child-pugh-score C)
- Known alcohol or other drug abuse
- Known active malignant disease
- Known thrombocytopenia (platelets \<50,000/µL), hemorrhagic diathesis (primary defects of coagulation, fibrinolysis, platelets)
- History of hypersensitivity to the investigational products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product
- Known allergy to heparin or history of heparin induced thrombocytopenia.
- Pregnancy and lactation
- Concomitant use of antithrombotic (with PTT \> 1.5 of normal PTT), thrombolytic treatment.
- Use of aspirin, clopidogrel or dipyridamole or combinations thereof (e.g. Aggrenox®) is not an exclusion criterion. These drugs should be discontinued and not restarted earlier than 24 hours after normalization of INR if indicated.
- Previous participation in this trial
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00928915
Start Date
July 1 2009
End Date
January 1 2015
Last Update
October 26 2016
Active Locations (1)
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1
Heidelberg University Clinic
Heidelberg, Germany, 69120