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Effect of Acute Normovolemic Haemodilution on Allogenic Transfusion Needs In Laparotomy

Effect of Acute Normovolemic Haemodilution on Allogenic Transfusion Needs in Patients Undergoing Laparotomy Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02290964
Acronym
ANH
Enrollment
34
Registered
2014-11-14
Start date
2010-03-31
Completion date
2010-05-31
Last updated
2014-11-14

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

Conditions

Surgery

Keywords

Acute normovolemic hemodilution, allogeneic transfusion

Brief summary

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)

Detailed description

Allogeneic blood transfusion is often done during surgery to save life- threatening conditions. Blood conservation is a method that can reduce peri-operative allogeneic blood transfusion. This study has been conducted on 34 patients underwent laparotomy surgery with bleeding more than 20% of EBV. After being informed concent, research subjects were randomized into two groups: ANH (conducted ANH) and control group (without ANH). After starting general anesthesia, the ANH group was withdrawing blood based on Gross formula. Restoration of circulated volume was instituted by infusion of colloids. In control group, the operation was started right after the induction of anesthesia. The monitoring of blood pressure, heart rate, the amount of bleeding, total fluid, urine production, hemoglobin concentration and number of allogenic transfusion were recorded.

Interventions

PROCEDUREANH

After general anesthesia is applied, blood was taken through the cubital vein and collected into standard blood bags containing CPDA anti-coagulant. The blood obtained is then stored at temperature of 23 - 25 Celsius degree and given back to patients in the operating room after the bleeding stopped and as soon as there are indications of transfusion.

Sponsors

Universitas Padjadjaran
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reduction of allogenic transfusion requirementsDuring surgery and 24 hours post surgery with target Hb > 8gr/dlThe 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

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026