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

November 13, 2014 updated by: Tatang Bisri, Universitas Padjadjaran

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia, 40161
        • Department of Anesthesiology and Therapy Intensive Faculty of Medicine/Dr. Hasan Sadikin General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
After general anesthesia is applied, surgery is performed. Whenever transfusion is indicated, the patients will received allogenic blood transfusion
Active Comparator: ANH group
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.
Procedure: ANH
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of allogenic transfusion requirements
Time Frame: 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
During surgery and 24 hours post surgery with target Hb > 8gr/dl

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Investigators

  • Study Chair: Heni H Listianto, MD, Department of Anesthesiology and Therapy Intensive Faculty of Medicine Universitas Padjadjaran Dr. Hasan Sadikin General Hospital Bandung

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

September 28, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 14, 2014

Study Record Updates

Last Update Posted (Estimate)

November 14, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AN-201409.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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