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

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ClinicalTrials.gov Identifier: NCT02290964
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Tatang Bisri, 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)

Condition or disease Intervention/treatment Phase
Surgery Procedure: ANH Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Acute Normovolemic Haemodilution on Allogenic Transfusion Needs in Patients Undergoing Laparotomy Surgery
Study Start Date : March 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

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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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290964


Locations
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Indonesia
Department of Anesthesiology and Therapy Intensive Faculty of Medicine/Dr. Hasan Sadikin General Hospital
Bandung, West Java, Indonesia, 40161
Sponsors and Collaborators
Universitas Padjadjaran
Investigators
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Study Chair: Heni H Listianto, MD Department of Anesthesiology and Therapy Intensive Faculty of Medicine Universitas Padjadjaran Dr. Hasan Sadikin General Hospital Bandung
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Responsible Party: Tatang Bisri, Professor in anesthesiology, MD., PhD, Universitas Padjadjaran
ClinicalTrials.gov Identifier: NCT02290964    
Other Study ID Numbers: AN-201409.01
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014
Keywords provided by Tatang Bisri, Universitas Padjadjaran:
Acute normovolemic hemodilution
allogeneic transfusion