Surgery Clinical Trial
— ANHOfficial title:
Effect of Acute Normovolemic Haemodilution on Allogenic Transfusion Needs in Patients Undergoing Laparotomy Surgery
Verified date | November 2014 |
Source | Universitas Padjadjaran |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: Ethics Committee |
Study type | Interventional |
This study is aimed to determine if acute normovolemic hemodilution (ANH), an established blood conservation technique, reduces the requirement for allogeneic blood transfusion in operations with prediction of surgical bleeding over 20% of estimated blood volume (EBV)
Status | Completed |
Enrollment | 34 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 79 Years |
Eligibility |
Inclusion Criteria: - Adult patients scheduled for laparotomy under general anesthesia with potentially surgical bleeding > 20% of EBV - ASA physical status I - II - hemoglobin level before surgery > 11 g / dl for men and > 10 g / dl for women Exclusion Criteria: - impaired coagulation (INR> 1.5 and / or platelet count <100,000) - active infection - disruption of metabolic liver - received anti fibrinolytic drugs |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | Department of Anesthesiology and Therapy Intensive Faculty of Medicine/Dr. Hasan Sadikin General Hospital | Bandung | West Java |
Lead Sponsor | Collaborator |
---|---|
Universitas Padjadjaran |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of allogenic transfusion requirements | The investigators evaluate number of patients require allogenic transfusion during surgery until 24 hours post surgery with targeted haemoglobin level > 8gr/dl. Blood pressure, heart rate, total bleeding, total fluid administration and urine production are also recorded in order to confirm that acute normovolemic haemodilution is safe in patients undergoing laparotomy surgery | During surgery and 24 hours post surgery with target Hb > 8gr/dl | Yes |
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