Effect of Acute Normovolemic Haemodilution on Allogenic Transfusion Needs In Laparotomy

NCT02290964 | Completed DMC

• 1 other identifier: AN-201409.01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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)

Conditions

Surgery

Keywords

Acute normovolemic hemodilution; allogeneic transfusion

Outcome Measures

Primary Outcomes (1)

• Reduction of allogenic transfusion requirements

  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

Study Arms (2)

Control group

NO INTERVENTION

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

ANH group

ACTIVE COMPARATOR

After general anesthesia is applied, blood from patients in this group were withdrawn. the volume of blood withdrawn was determined based on Gross equation.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

Interventions

ANH 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.

ANH group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• impaired coagulation (INR\> 1.5 and / or platelet count \<100,000)
• active infection
• disruption of metabolic liver
• received anti fibrinolytic drugs

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

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

Bandung, West Java, 40161, Indonesia

Location

Study Officials

• Heni H Listianto, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in anesthesiology, MD., PhD

Study Record Dates

• First Submitted: September 28, 2014
• First Posted: November 14, 2014
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

ID (1)