International Normalized Ratio (INR) Normalization in Coumadin Associated Intracerebral Haemorrhage "INCH"

Terminated

Phase 4 Results N/A

Update History

29 May '15
A location was updated in Heidelberg.
New
The overall status was removed for Heidelberg University Clinic.
6 Oct '11
The eligibility criteria were updated.
New
Inclusion Criteria: - 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 Criteria: - 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
Old
Inclusion Criteria: - 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 Criteria: - 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