Iron Alone or Iron and Erythropoietin Added to Acute Normovolemic Hemodilution in myomectomy patients : A Randomized controlled Trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000152527
• Date of registration: 17/02/2015
• Prospective Registration: No
• Primary sponsor: Hoda Alsaid Ahmed Ezz
• Public title: Iron Alone or Iron and Erythropoietin Added to Acute Normovolemic Hemodilution in myomectomy patients : A Randomized controlled Trial
• Scientific title: Effect of Iron Alone or Iron and Erythropoietin Added to Acute Normo-volemic Hemo-dilution as a Blood conservative Strategy on Transfusion Requirements in Elective Myomectomy Patients.
• Date of first enrolment: 01/09/2012
• Target sample size: 90
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000152527.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Egypt

Contacts

• Name: Prof Abd Elraheem M Dowidar

• Name: Prof Abd Elraheem M Dowidar

Key inclusion & exclusion criteria

Inclusion criteria: Female patients patients aged between 18 and 60 years old , with hemoglobin level more than 12 g /dl at the time ANH and scheduled for elective myomectomy at the Gynecology and Obstetric Department, Tanta University Hospital
Exclusion criteria: Patients who refused to participate in the study, aged < 18 or more than 60 years, with hemoglobin less than 12 g/dl at the time of ANH, received blood or blood components in the preceding 4 weeks, with severe hepatic, renal or heart disease were excluded from the study.

Age minimum: 18 Years
Age maximum: 60 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Blood - Anaemia

myomectomy surgery;uterine fibroids;
myomectomy surgery
uterine fibroids

Anaesthesiology - Other anaesthesiology

Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

Intervention(s)

Patients were randomly allocated into three equal groups (30 patients each). Group I (control group): Patients scheduled for acute normo-volemic hemodilution (ANH) alone after induction of general anesthesia. Group II: Patients received oral ferrous iron sulfate 320 mg tablets twice daily for 2 weeks before surgery and scheduled for ANH after induction of general anesthesia. Group III : Patients received oral ferrous iron sulfate 320 mg tablets twice daily and recombinant human erythropoietin (rHuEPO) in a dose of 100 IU /kg subcutaneously twice a week for 2 weeks before surgery and scheduled for ANH after induction of general anesthesia.
The ANH was started just after tracheal intubation through the internal jugular vein. The volume to be withdrawn was calculated (maximum 3 unites), while maintaining the Hct level more than 28%. The first 1000 cc of blood withdrawn was replaced with equal volume of hydroxyl-ethyl starch 6%, then any additional blood was replaced with crystalloid solution in the ratio of 3:1.
The volume of blood that could be withdrawn during ANH from each patient was calculated using the following formula:
V = EBV × (Hi – Hf )/ Hav
V = Volume of blood that could be removed
EBV = Estimated blood volume Hi = initial hematocrite level Hf = the target hematocrite level following ANH
Hav = the average hematocrite level of Hi and Hf.
The number of blood units withdrawn by ANH was recorded.
The volume of blood loss was estimated by estimation of blood in the surgical sponges (5 = mildly, 10 =moderately, and 15 = severely soaked) and pads (50 = mildly, 100 = moderately, and 150 = severely soaked) and, observing the volume of blood in the suction apparatus and the surgical drains.
Blood trans

Primary Outcome(s)

The number of homologous blood units they received were recorded[ in the first 3 post-operative days ]

The number (and percentage )of patients in each group who received homologous blood transfusion were recorded. [in the first 3 post-operative days ]

Secondary Outcome(s)

The occurrence of any complication e.g hypertension, was recorded. [Measurement of arterial blood pressure daily during the study period from start of the study till 3 days post-operative.]

Hematocrite (Hct)% [Serum assays measured Preoperatively; 2 weeks (baseline values) and one week before surgery. Intra-operatively; just before induction of anesthesia, immediately after ANH then at 30, 60, 90, 120 minutes and at the end of surgery. Postoperatively; after 2 hours and once daily for the first 3 days.]

The number of blood units withdrawn by ANH was recorded[During ANH]

The volume of blood (ml) that could be withdrawn during ANH from each patient [During ANH]

The volume of blood loss (ml) was estimated by estimation of blood in the surgical sponges (5 = mildly, 10 = moderately, and 15 = severely soaked) and pads (50 = mildly, 100=moderately, and 150 = severely soaked) and, observing the volume of blood in the suction apparatus and the surgical drains.[In the inra- and post-operative period till 3 days postoperatively.]

Hemoglobin (Hb) g/dl [Serum assays measured preoperatively ; 2 weeks (baseline values) and one week before surgery. Intra-operatively; just before induction of anesthesia, immediately after ANH then at 30, 60, 90, 120 minutes and at the end of surgery. Postoperatively; after 2 hours and once daily for the first 3 days.]

Secondary ID(s)

nil

Source(s) of Monetary Support

Mai Mokhtar M kasem

Hoda Alsaid Ahmed Ezz.

Abd El Raheem M. Dowidar

Ayman Abd El Aziz El Dorf

Secondary Sponsor(s)

Abd El Raheem M. Dowidar.

Ayman Abd El Aziz El dorf

Mai Mokhtar M Kasem

Ethics review

Status: Approved
Approval date:
Contact:

The Research Ethics Committee of the Faculty of Medicine, Tanta, Egypt.