Standard medical treatment, including routine antiplatelet, blood pressure control, statins to stabilize plaque, etc.

Argatraban is used on the basis of standard medical treatment.

Acute Progressive Ischemic Stroke

Argatroban plus standard medical treatment

Argatroban

Min Lou

People's Hospital of Anji

Jiaxing Second Hospital

Ninghai First Hospital

Quzhou Kecheng People's Hospital

Tongxiang Diyi Renmin Hospital

Clinical Study of Argatroban in the Treatment of Acute Progressive Ischemic Stroke

NIHSS 0-42, higher indicate worse outcome

Complex events include cerebrovascular events, myocardial infarction, angina pectoris and systemic embolism.

Barthel Index 0-100, higher indicate better outcome

Increase of National Institute of Health stroke scale(NIHSS) scores caused by intracranial hemorrhage confirmed by imaging ≥ 4 points.

parenchymal hematoma is assessed on MRI or CT according to the second European-Australasian acute stroke study (ECASS II).

Second Affiliated Hospital, School of Medicine, Zhejiang University

Morphine group (n=700), where patients will be treated with i.v. injection of Morphine 2,5 mg diluted in 10 ml of NaCl 0,9%. The treatment will be given during CPR as soon as possible.

Ketamine group (n=700), where patients will be treated with i.v. injection of Ketamine 50 mg diluted in 10 ml of NaCl 0,9%. The treatment will be given during CPR as soon as possible.

Control group (n=700), where patients will be treated with i.v. 10 ml of NaCl 0,9%. The treatment will be given during CPR as soon as possible.

Cardiac Arrest

Adult patients with an out-of-hospital cardiac arrest will be evaluated by skilled paramedics or prehospital trained anaesthesiologists for inclusions criteria to the study and randomised to get the blinded study medicine as addition to standard treatment of cardiac arrest. Randomization will be performed by means of sealed envelopes containing number of syringe that will be used.

Morphine

Ketamine Injectable Solution

Saline 0.9%

Morphine or/and Ketamine in Out-of-hospital Cardiac Arrest

Treatment of Patients With Morphine or/and Ketamine During Out-of-hospital Cardiac Pulmonary Resuscitation

Survival rate at 30 days in patients after out-ofhospital cardiac arrest treated or not with Morphine or ketamine during CPR

Measurement of biochemical markers of brain damage (NSE, S-100B protein) at 2,12, 24 and 48 hours in patients after out-of-hospital cardiac arrest.

Registration of length of patients stay (days) in the intensive care units

Registration of patients stay (days) in the hospitals

Registration of survival rate at 3 months after cardiac arrest

Modified Rankin Scale (mRS) will be used for evaluation of neurological outcome. The mRS-9Q Survey and web calculator / error-checker can be accessed freely at:
www.modifiedrankin.com. The mRS score encodes meaningful levels of function from no symptoms or functional impairment (mRS score = 0) through to severe disability requiring constant nursing care (mRS score = 5). the mRS-9Q is an easy-to-use tool to determine the mRS score with very good interobserver reliability and reproducibility. Web-based calculator can be also administered by personnel without clinical training, either in person or by telephone.

Vladimir Kuklin

Head of day case surgery unit

University Hospital, Akershus

Adult patients who have sustained an out-of-hospital cardiac arrest for which advanced life support will be provided by skilled paramedics or prehospital trained anaesthesiologists will be eligible for inclusion.

Every ambulance car or helicopter on duty in the city of Oslo and Vestre Viken Hospital Trust will have a trial pack containing 10 pre-filled 10 ml syringes that will be labeled with only randomisation number. Paramedics or prehospital trained anaesthesiologists will not know the content of the syringes as well as a meaning of the randomisation number. The pharmacy of Akershus university hospital will be responsible to prepare the syringes.

Term Hypoxic Ischaemic Encephalopathy (HIE)

Hypoxic Ischaemic Encephalopathy (HIE)

Asphyxia

Click here for more information on the BiHIVE Study

Cork University Maternity Hospital

Karolinska University Hospital

BiHiVE2 Study. The Investigation and Validation of Predictive Biomarkers in Hypoxic-ischaemic Encephalopathy.

BiHiVE 2 Study. The Investigation and Validation of Predictive Biomarkers in Hypoxic-ischaemic Encephalopathy.

Clinical examination using the Thompson Encephalopathy score and visual interpretation of multichannel EEG

brain edema/protease

Clinical Study of Argatroban in the Treatment of Acute Progressive Ischemic Stroke

Morphine or/and Ketamine in Out-of-hospital Cardiac Arrest

BiHiVE2 Study. The Investigation and Validation of Predictive Biomarkers in Hypoxic-ischaemic Encephalopathy.

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