Effect of Acute Normovolemic Haemodilution on Allogenic Transfusion Needs In Laparotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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After general anesthesia is applied, blood from patients in this group were withdrawn. the volume of blood withdrawn was determined based on Gross equation.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

Group Type ACTIVE_COMPARATOR

ANH

Intervention Type PROCEDURE

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.

Control group

After general anesthesia is applied, surgery is performed. Whenever transfusion is indicated, the patients will received allogenic blood transfusion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Tatang Bisri

Professor in anesthesiology, MD., PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heni H Listianto, MD

Role: STUDY_CHAIR

Department of Anesthesiology and Therapy Intensive Faculty of Medicine Universitas Padjadjaran Dr. Hasan Sadikin General Hospital Bandung

Locations

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Department of Anesthesiology and Therapy Intensive Faculty of Medicine/Dr. Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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AN-201409.01

Identifier Type: -

Identifier Source: org_study_id