Multicenter, prospective randomized trial on the use of prothrombin complex and fresh frozen plasma in patients with intracerebral hemorrhage related to vitamin K antagonists (VKA) - ICH-VKA

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10022754Term: Intracerebral hemorrhageSystem Organ Class: 10029205 - Nervous system disorders; Intracerebral hemorrhage (ICH) in patients related to vitamin K antagonists

• Registration Number: EUCTR2008-005653-37-DE
• Lead Sponsor: niversityhospital of Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-14
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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 <50,000/?L), hemorrhagic diathesis (primary defects of coagulation, fibrinolysis, platelets)
5. Pregnancy and lactation
6. Acute myocardial ischemia, acute septicemia, acute crush injury, any history of acute hemorrhagic disseminated intravascular coagulation, acute thrombotic stroke
7. Acute or known congestive heart failure (NYHA III, IV)
8. Pulmonary edema
9. Known history of claudicatio intermittens
10. Known recent thrombotic event < 30 days
11. Known active malignant disease
12. Known alcohol or other drug abuse
13. Known previous disability (mRS > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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