The Efficacy and Safety Study of ALbumin Therapy in Acute Ischemic Stroke

Cerebral Infarction Clinical Trial

— ALbumin  

Official title:

A Phase IIB Placebo Comparative, Double Blinded, Randomized, Multi-center Study to Evaluate the Efficacy and Safety of ALbumin Therapy in Acute Ischemic Stroke Patients in Korea.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01684462
• Other study ID #: AL_IIT_01
• Status: Terminated
• Phase: Phase 2
• First received: August 21, 2012
• Last updated: November 28, 2013
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: November 2013
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationKorea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In this clinical study, the efficacy and safety of ALbumin is to be evaluated for the patients occurred within 12 hours of acute ischemic stroke.

Description:

According to the statistics of the cause of death in 2008 by the Statistics Korea, the stroke was accounted for a large proportion of cause of death among adults, as well as higher mortality, severe sequelae. These stroke in acute phase showed neurological deterioration over 50% of the patients after beginning of treatment and the sequelae resulting in that the nervous tissue was not regenerated is regarded as irreversible changes.

The test group administered 20% albumin based on 1.25g/kg (up to 100g (500ml) over 80kg body weight) to the patients occurred within 12 hours of the onset of symptoms and equal amount of placebo (saline solution (0.9% normal saline)) administered to the control group will be compared to evaluate the efficacy and safety of ALbumin for the patients with acute ischemic stroke.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• At least 18 years of age less than 75 years old

• Patients who can be administered ALbumin within 12hours of onset of acute ischemic stroke

• 5 = NIHSS score < 15

• Patients who are agreed by guardian or legal representative in case that patients have no ability to join study voluntarily

Exclusion Criteria:

• Medical history of congestive heart failure or patients who are judged congestive heart failure on admission.

• Patients with cardiac edema or pulmonary edema.

• Medical history of myocardial infarction within the past six months.

• Patients who have serious aortic stenosis and mitral valve stenosis.

• Signs or symptoms of acute MI on admission (Serum troponin level =0.1 ug/L)

• Those Who had cardiac surgery.

• Onset of cerebral infarction within the past three months.

• Before onset of cerebral infarction, patients who were diagnosed as Historical mRS = 2.

• Patients who received treatment of thrombolysis or who planned for treatment of thrombolysis.

• Acute tachyarrhythmia or bradyarrhythmia with hemodynamic instability on admission.

• Acute or chronic lung disease requiring supplemental O2 therapy on admission

• Severe anemia (Hb < 8.0)

• Severe dehydration (defined as decreased skin turgor, dry oral mucous membrane, tachycardia(>100/min), and oliguria)

• Fever, defined as core body temperature>37.5 ?

• Serum creatinine > 2.0 mg/dL

• History of allergy to albumin.

• Patients who have side effects of albumin (hyperergia to shock, fever, facial flushing,urticarial, algor, lumbodynia)

• Pregnancy

• Patients who are in life-threatening or stupor coma situation.

• Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on admission CT or MRI scan.

• Patients who are not the normal, excesses of circulating blood.

• Haemolytic anemia, anemia due to blood loss.

• Immunodeficiency disease, immunosuppression.

• Blood pressure higher than 180/110 mmHg on admission.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction

Intervention

Biological:
• Human Serum Albumin 20
Human Serum Albumin 20% 100cc albumin 1.25g/kg up to 100g (500ml) intravenously infused over 4~8h, commencing within 12 hours of stroke onset

Drug:
• 0.9 % Normal Saline
Infusion of 100 mL of 0.9% Normal Saline ( equivalent volume of Albumin ) over 4~8h, commencing within 12 hours of stroke onset

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Mok-dong	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seocho-Gu	Seoul
Korea, Republic of	St. Vincent's hospital	Suwon	Gyeonggido
Korea, Republic of	Yeoudo St. Mary's hospital	Yeongdeungpo-Gu	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average change in NIHSS	Comparison of the average change in NIHSS between the control and ALbumin group at screening(-12h~0days) and 14±3days	at 14±3days	Yes
Secondary	NIHSS Score	Comparison of NIHSS score between the control and ALbumin group at 14±3days	at 14±3days	Yes
Secondary	Proportion of patients with improvement by NIHSS	Comparison of the proportion of patients with improvement in NIHSS over 4 at 14±3days.	at 14±3days	Yes
Secondary	modified Rankin Scale(mRS) favorable outcome	Comparison of the global functional outcome on modified Rankin Scale(mRS) at screening(-12h~0days) and 3 months.	at 3 months	Yes
Secondary	Volume difference on diffusion MRI	Comparison of the volume difference of cerebral infraction defined by diffusion MRI at 4±1days	at 4 days±1days	Yes
Secondary	Recurrent new ischemic lesions on diffusion MRI	Comparison of the proportion of patients who appear to be recurrent new ischemic lesions defined by diffusion MRI	at 4±1days	Yes