Effect of Acute Normovolemic Haemodilution on Allogenic Transfusion Needs In Laparotomy

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Procedure: ANH

• Registration Number: NCT02290964
• Lead Sponsor: Universitas Padjadjaran

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.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2014-09-28
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-13
• Last Update Submitted: 2014-11-13
• Study First Posted: 2014-11-14
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ANH group	ANH	After general anesthesia is applied, blood from patients in this group were withdrawn. the volume of blood withdrawn was determined based on Gross equation.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.

Primary Outcome Measures

Name	Time	Method
Reduction of allogenic transfusion requirements	During surgery and 24 hours post surgery with target Hb > 8gr/dl	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

Trial Locations

Locations (1)

Department of Anesthesiology and Therapy Intensive Faculty of Medicine/Dr. Hasan Sadikin General Hospital; 🇮🇩 Bandung, West Java, Indonesia