NCT00928915

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

Multicenter, Prospective Randomized Trial on the Use of Prothrombin Complex and Fresh Frozen Plasma in Patients With Intracerebral Hemorrhage Related to Vitamin K Antagonists

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 in non-anticoagulated patients. Mortality may rise up to 67%. The higher mortality rate may in part be due to the higher rate of haematoma expansion (HE) over a longer period after symptom onset. International guidelines recommend treatment of VKA-ICH with prothrombin complex (PCC) or fresh-frozen plasma (FFP) both in combination with Vitamin-K. But these recommendations are not based on randomized controlled trials. It is known that these drugs lower the INR, and thus it is assumed that normalization of coagulopathy may lead to haemostasis and reduction of HE. Safety and efficacy of these treatments have never been studied in a prospective controlled trial. The investigators' questions are: How potent are PCC and FFP in normalization of the INR? What is the safety profile of each of these drugs?

Conditions

• Intracranial Hemorrhages

Interventions

Type	Name	Description
DRUG	Prothrombin complex concentrate (PCC); fresh frozen plasma (FFP)	intravenous, repeated until INR ≤ 1.2

Timeline

• Start date: 2009-07-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2009-06-26
• Last updated: 2016-10-26

Locations

1 site across 1 country: Germany