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

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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000152527
Enrollment
90
Registered
2015-02-17
Start date
2012-09-01
Completion date
2013-09-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this work was to study the effect of adding erythropoien and iron or iron alone to ANH on blood transfusion requirements in elective myomectomy patients.

Interventions

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

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 The volume to be withdrawn was calculated (maximum 3 unites), while maintaining the Hct level more than 28%. The first 1000 cc of blood withdrawn was replaced with equal volume of hydroxyl-ethyl starch 6%, then any additional blood was replaced with crystalloid solution in the ratio of 3:1. The volume of blood that could be withdrawn during ANH from each patient was calculated using the following formula: V = EBV × (Hi – Hf )/ Hav V = Volume of blood that could be removed EBV = Estimated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 transfusion was given if Hb level was < 8 g/dl and, if there was abnormal ECG, ischemic heart disease or obstructive lung disease and the Hb level was 8-10 g/dl. No transfusion was given if Hb level was more than 10 g/dl. If the patient was in-need for blood transfusion, the blood removed by ANH was given first, starting with the last unit collected then, homologous blood. At the end of surgery all autologous blood was returned to the patient. The first 1000 cc of blood withdrawn by ANH were replaced with equal volume of 6% hydroxyethyl starch. Subsequent blood withdrawn was replaced with ringer’s solution at a ratio of 3 :1. All patients were pre-medicated with 0.01 mg/kg midazolam intravenous before induction of anesthesia and monitored for ECG, oxygen saturation, capnography and non-invasive blood pressure. A urinary catheter was inserted for collection of urine output.

Sponsors

Hoda Alsaid Ahmed Ezz
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026