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Effect of Acute Normovolemic Haemodilution on Allogenic Transfusion Needs In Laparotomy (ANH)

U

Universitas Padjadjaran

Status

Completed

Conditions

Surgery

Treatments

Procedure: ANH

Study type

Interventional

Funder types

Other

Identifiers

NCT02290964
AN-201409.01

Details and patient eligibility

About

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)

Full 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.

Enrollment

34 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

34 participants in 2 patient groups

Control group
No Intervention group
Description:
After general anesthesia is applied, surgery is performed. Whenever transfusion is indicated, the patients will received allogenic blood transfusion
ANH group
Active Comparator group
Description:
After general anesthesia is applied, blood from patients in this group were withdrawn. the volume of blood withdrawn was determined based on Gross equation. The blood obtained was then stored in the operating room at temperature between 23 - 25 Celsius degree, and given back to the patient whenever transfusion is indicated.
Treatment:
Procedure: ANH

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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