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Trial registered on ANZCTR


Registration number
ACTRN12615000152527
Ethics application status
Approved
Date submitted
7/12/2014
Date registered
17/02/2015
Date last updated
8/02/2016
Type of registration
Retrospectively registered

Titles & IDs
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.
Secondary ID [1] 285799 0
nil
Universal Trial Number (UTN)
U111-1164-9547
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myomectomy surgery 293692 0
uterine fibroids 293921 0
Condition category
Condition code
Blood 293993 293993 0 0
Anaemia
Anaesthesiology 294224 294224 0 0
Other anaesthesiology
Reproductive Health and Childbirth 294225 294225 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 The volume to be withdrawn was calculated (maximum 3 unites), while maintaining the Hct level more than 28%. The first 1000 cc of blood withdrawn was replaced with equal volume of hydroxyl-ethyl starch 6%, then any additional blood was replaced with crystalloid solution in the ratio of 3:1.
The volume of blood that could be withdrawn during ANH from each patient was calculated using the following formula: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.
Intervention code [1] 290770 0
Treatment: Drugs
Intervention code [2] 290773 0
Treatment: Other
Comparator / control treatment
control group is group I in which the patients were scheduled for ANH alone after induction of general anesthesia.
Control group
Active

Outcomes
Primary outcome [1] 293773 0
The number (and percentage )of patients in each group who received homologous blood transfusion were recorded.
Timepoint [1] 293773 0
in the first 3 post-operative days
Primary outcome [2] 293774 0
The number of homologous blood units they received were recorded
Timepoint [2] 293774 0
in the first 3 post-operative days
Secondary outcome [1] 311794 0
Hemoglobin (Hb) g/dl
Timepoint [1] 311794 0
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 outcome [2] 311795 0
Hematocrite (Hct)%
Timepoint [2] 311795 0
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 outcome [3] 311796 0
The volume of blood (ml) that could be withdrawn during ANH from each patient
Timepoint [3] 311796 0
During ANH
Secondary outcome [4] 311797 0
The number of blood units withdrawn by ANH was recorded
Timepoint [4] 311797 0
During ANH
Secondary outcome [5] 311798 0
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.
Timepoint [5] 311798 0
In the inra- and post-operative period till 3 days postoperatively.
Secondary outcome [6] 311799 0
The occurrence of any complication e.g hypertension, was recorded.
Timepoint [6] 311799 0
Measurement of arterial blood pressure daily during the study period from start of the study till 3 days post-operative.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization between group II and III (treatment groups) was done using closed sealed envelops and computer generated random numbers two weeks before surgery. While, patients of the control group were selected randomly at the time of operation using closed sealed envelops and computer generated random numbers. A blinded nurse, who did not participate in data collection read the patients number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
using closed sealed envelops and computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2012
Actual
1/09/2012
Date of last participant enrolment
Anticipated
1/09/2013
Actual
1/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 6513 0
Egypt
State/province [1] 6513 0

Funding & Sponsors
Funding source category [1] 290362 0
Self funded/Unfunded
Name [1] 290362 0
Hoda Alsaid Ahmed Ezz.
Country [1] 290362 0
Egypt
Funding source category [2] 290391 0
Self funded/Unfunded
Name [2] 290391 0
Abd El Raheem M. Dowidar
Country [2] 290391 0
Egypt
Funding source category [3] 290396 0
Self funded/Unfunded
Name [3] 290396 0
Ayman Abd El Aziz El Dorf
Country [3] 290396 0
Egypt
Funding source category [4] 290397 0
Self funded/Unfunded
Name [4] 290397 0
Mai Mokhtar M kasem
Country [4] 290397 0
Egypt
Primary sponsor type
Individual
Name
Hoda Alsaid Ahmed Ezz
Address
El Geish Street, Department of anesthesiology and surgical intensive care, Faculty of Medicine, Tanta University, Tanta, El Gharbia governorate, Egypt.
The postal code:31257
Country
Egypt
Secondary sponsor category [1] 289084 0
Individual
Name [1] 289084 0
Abd El Raheem M. Dowidar.
Address [1] 289084 0
El Geish Street, Department of anesthesiology and surgical intensive care, Faculty of Medicine, Tanta University, Tanta, El Gharbia governorate, Egypt.
The postal code:31257
Country [1] 289084 0
Egypt
Secondary sponsor category [2] 289085 0
Individual
Name [2] 289085 0
Ayman Abd El Aziz El dorf
Address [2] 289085 0
El Geish Street, Gynacology and Obestetric department Faculty of Medicine, Tanta University, Tanta, El Gharbia governorate, Egypt.
The postal code:31257
Country [2] 289085 0
Egypt
Secondary sponsor category [3] 289086 0
Individual
Name [3] 289086 0
Mai Mokhtar M Kasem
Address [3] 289086 0
El Geish Street, Department of anesthesiology and surgical intensive care, Faculty of Medicine, Tanta University, Tanta, El Gharbia governorate, Egypt.
The postal code:31257
Country [3] 289086 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292066 0
The Research Ethics Committee of the Faculty of Medicine, Tanta, Egypt.
Ethics committee address [1] 292066 0
Ethics committee country [1] 292066 0
Egypt
Date submitted for ethics approval [1] 292066 0
Approval date [1] 292066 0
30/05/2012
Ethics approval number [1] 292066 0
1168/04/12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52918 0
A/Prof Hoda Alsaid Ahmed Ezz
Address 52918 0
El Geish street, Department of anesthesiology and surgical intensive care faculty of medicine, Tanta University, Tanta, El Gharbia governorate, Egypt.
The postal code:31257
Country 52918 0
Egypt
Phone 52918 0
+20 1222768250
Fax 52918 0
Email 52918 0
hodaezz714@yahoo.com
Contact person for public queries
Name 52919 0
Abd Elraheem M Dowidar
Address 52919 0
El Geish street, Department of anesthesiology and surgical intensive care faculty of medicine, Tanta University, Tanta, El Gharbia governorate, Egypt.
The postal code:31257
Country 52919 0
Egypt
Phone 52919 0
+20 1223195015
Fax 52919 0
Email 52919 0
dr.dowidar47@hotmail.com
Contact person for scientific queries
Name 52920 0
Abd Elraheem M Dowidar
Address 52920 0
El Geish street, Department of anesthesiology and surgical intensive care faculty of medicine, Tanta University, Tanta, El Gharbia governorate, Egypt.
The postal code:31257
Country 52920 0
Egypt
Phone 52920 0
+20 1223195015
Fax 52920 0
Email 52920 0
dr.dowidar47@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIron alone or iron and erythropoietin added to acute normovolemic hemodilution in myomectomy patients: A randomized controlled trial.2016https://dx.doi.org/10.1016/j.egja.2015.09.013
N.B. These documents automatically identified may not have been verified by the study sponsor.