Intracranial Hemorrhages Clinical Trial
Official title:
Multicenter, Prospective Randomized Trial on the Use of Prothrombin Complex and Fresh Frozen Plasma in Patients With Intracerebral Hemorrhage Related to Vitamin K Antagonists
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?
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03969732 -
Multimodal Biomarkers for Diagnosis and Prognosis in CAA
|
Phase 3 | |
| Recruiting |
NCT05968053 -
Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
|
||
| Recruiting |
NCT02962349 -
TRansfusion Strategies in Acute Brain INjured Patients
|
N/A | |
| Recruiting |
NCT03950076 -
EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)
|
Phase 4 | |
| Completed |
NCT03542656 -
Application of Amyloid PET in Cerebral Amyloid Angiopathy
|
Phase 3 | |
| Active, not recruiting |
NCT05626504 -
Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms
|
||
| Recruiting |
NCT03495206 -
Safety, Tolerability and Pharmacokinetics of Y-2(Edaravone And Borneol) Sublingual Tablet
|
Phase 1 | |
| Not yet recruiting |
NCT04229758 -
Restarting Anticoagulation After Traumatic Intracranial Hemorrhage
|
Phase 3 | |
| Recruiting |
NCT02135783 -
Decompressive Craniectomy Combined With Hematoma Removal to Treat ICH
|
N/A | |
| Enrolling by invitation |
NCT02050971 -
Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates
|
Phase 1 | |
| Completed |
NCT01193270 -
Vitamin E for Extremely Preterm Infants
|
Phase 1 | |
| Completed |
NCT02881957 -
Hypovitaminosis D in Neurocritical Patients
|
Phase 2/Phase 3 | |
| Completed |
NCT03364634 -
Intracranial Pressure After Decompressive Craniectomy
|
N/A | |
| Completed |
NCT00226096 -
Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage
|
N/A | |
| Recruiting |
NCT06081283 -
Antiseizure Medication in Seizure Networks at Early Acute Brain Injury
|
Phase 4 | |
| Recruiting |
NCT04459806 -
Intracranial PrEssure Time dOse (ImPETO)
|
||
| Recruiting |
NCT05874050 -
Arterial Pressure and Surgical Hemostasis in Elective Neurosurgery.
|
||
| Not yet recruiting |
NCT05138341 -
Minimal Invasive Surgical Intracerebral Hemorrhage Removal
|
N/A | |
| Terminated |
NCT03660618 -
LSFG-SKIN, Laser Speckle Flowgraphy
|
N/A | |
| Recruiting |
NCT06370520 -
Screening Emotions in Adolescents at the Hospital for mTBI
|