Acute treatment of stroke in patients reciving anticoagulant treatment

Phase 1

Active, not recruiting

• Conditions: Intracerebral hemorrhage (ICH) in patients related to vitamin K antagonists; MedDRA version: 14.1Level: LLTClassification code 10022754Term: Intracerebral hemorrhageSystem Organ Class: 100000004852; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-21
• Last Update Posted: 12 September 2016

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 74

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

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

1 Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, hemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma
2. Deep Coma (GCS = 5) at the time of admission or before intubation if intubated outside the hospital
3. Known thrombocytopenia (platelets <50,000/?L), hemorrhagic diathesis (primary defects of coagulation, fibrinolysis, platelets)
4. Pregnancy and lactation
5. Acute myocardial ischemia, acute septicemia, acute crush injury, any history of acute hemorrhagic disseminated intravascular coagulation, acute thrombotic stroke
6. Acute or known congestive heart failure (NYHA III, IV)
7. Pulmonary edema
8. Known history of claudicatio intermittens
9. Known recent thrombotic event < 30 days
10. Known active malignant disease
11. Known alcohol or other drug abuse
12. Known previous disability (mRS > 2 before stroke occurred)
13. Known liver failure (child-pugh-score C)
14. 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
15. Known allergy to heparin or history of heparin induced thrombocytopenia.
16. Previous participation in this trial
17. 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): Number of patients with INR = 1.2 3 hours after start of drug infusion;Timepoint(s) of evaluation of this end point: 3 hours after initiation of study drug

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Time to normalisation of INR (measured 30 min and 3 hours after start of infusion, or at the end of infusion if FFP is terminated before 3 hours)<br>2. Hematomagrowth defined as change in hematoma volume within 24 hours. <br>3. Modified rankin Scale, at day 15 and 90.<br>4. National Institute of health Stroke Scale at 15 days.<br>5. Glasgow outcome scale at day 90.<br>6. Barthel Index at day 90.<br>EQ-5D self-report questionnaire (Quality of life at day 90.<br>;Timepoint(s) of evaluation of this end point: The above mentioned end points are evaluated at 15 days or 90 days as described under the individual items above