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Effect of Albumin on size of hematoma in Hemorrhagic Stroke

Assessment of the effect of Albumin compared with Placebo on the reduction of the hematoma volume in patients with Hemorrhagic Stroke referred to Ahvaz Golestan Hospital

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201201018574N1
Enrollment
60
Registered
2013-02-13
Start date
2011-09-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhagic Stroke. Intracerebral Haemorrhage, Unspecified

Interventions

Intervention 1: Vials of human Albumin 20% : 1 gram per kiloogram body weight divided in 7 days within daily IV infusion during 2 hours. Intervention 2: Saline 0.9% (with an equal volume of 1 gr/kg fr
Treatment - Drugs
Placebo
Saline 0.9% (with an equal volume of 1 gr/kg from human Albumin 20% vial) in 7 days within 2 hours IV infusion
Vials of human Albumin 20% : 1 gram per kiloogram body weight divided in 7 days within daily IV infusion during 2 hours

Sponsors

Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 149 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria : Primary Hemorrhagic Stroke; 24 hours from symptom onset; Above 18 years old. Exclusion Criteria : Hematoma volume less than 7 ml; Need surgical evacuation; Pregnancy; Lactation; Systolic blood pressure less than 100 mmHg or more than 250 mmHg; Anticoagulant or Thrombolytic therapy; Serum Creatinine more than 2 mg/dl; History of known allergy to Albumin; History of severe allergic reactions known as latex gloves; Exacerbation of congestive heart failure within the past 6 months; Acute myocardial infarction in the last 6 months.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The hematoma volume. Timepoint: Befor intervention, The end of intervention (One week). Method of measurement: The hematoma volume on CT scan (ml) : Length of maximum appearance of hematoma (cm) × Width of same cut (cm) × Number of cuts including bleeding / 2.

Secondary

MeasureTime frame
Neurological deficits. Timepoint: Befor intervention, After one month. Method of measurement: NIHSS criteria.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDavood Shalilahmadi, MD

Ahvaz Jundishapur University of Medical Sciences

shalilahmadi.d@ajums.ac.ir+98 61 1374 3012

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026