Effect of Acute Normovolemic Haemodilution on Allogenic Transfusion Needs In Laparotomy

Surgery Clinical Trial

— ANH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290964
• Other study ID #: AN-201409.01
• Status: Completed
• Phase: N/A
• First received: September 28, 2014
• Last updated: November 13, 2014
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: November 2014
• Source: Universitas Padjadjaran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgery

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Department of Anesthesiology and Therapy Intensive Faculty of Medicine/Dr. Hasan Sadikin General Hospital	Bandung	West Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Padjadjaran

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes