Intracerebral hemorrhage (ICH) in patients related to vitamin K antagonists MedDRA version: 14.1 Level: LLT Classification code 10022754 Term: Intracerebral hemorrhage System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Octaplex
Pharmaceutical Form: Powder and solvent for suspension for injection
Product Name: Fresh frozen plasma
Pharmaceutical Form:
INN or Proposed INN: human plasma coagulation factors
Sponsors
Universityhospital of Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Therapy receiving vitamin K antagonists (VKA) 3. International Normalized Ratio (INR) = 2 4. Male or female subjects, age = 18 years 5. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with primary ICH 2. Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, hemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma 3. Deep Coma (GCS = 5) at the time of admission or before intubation if intubated outside the hospital 4. Known thrombocytopenia (platelets 2 before stroke occurred) 14. Known liver failure (child-pugh-score C) 15. 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 16. Known allergy to heparin or history of heparin induced thrombocytopenia. 17. Previous participation in this trial 18. Participation in ANY clinical trial within 30 days of entry into the trial and during the trial 19. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of PCC compared to FPP in patients with ICH-VKA;Secondary Objective: Safety and efficacy of PCC compared to FPP in patients with ICH-VKA;Primary end point(s): INR = 1.2 within 3 hours after start of drug infusion | — |
Countries
Germany
Outcome results
None listed