Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04061655

Collaborator

(none)

Enrollment

Location

Arms

3.7

Actual Duration (Months)

21.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A total of 80 patients will be randomly allocated into 2 groups, group A and placebo group using concealed envelope method.Group A patients (n= 40)will receive single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg. Patients in the placebo group (n=40) will receive as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.

Condition or Disease	Intervention/Treatment	Phase
Complications	Drug: Iron Isomaltoside 1000 Other: placebo	Early Phase 1

Detailed Description

A total of 80 patients will randomly allocated into 2 groups, group A and placebo group using concealed envelope method.Group A patients (n= 40) will receive single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg. Patients in the placebo group (n=40) will receive as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.

General anesthesia will the institutional standards and all surgeries will be performed by the same surgical team.Standardized monitoring will be applied.After median sternotomy,CPB will be established with 1500 ml crystalloid priming volume and mild hypothermia (32°C) with a Trillium Affinity oxygenator (Medtronic,Minneapolis, Minnesota, USA) and a Sarns CPB machine (Harrison, Mt. Clemens, Michigan, USA) at a flow rate of 2.6 lmin-1m-2.Myocardial protection will be done using cold blood cardioplegia at 20°C. During CPB, homologous donor packed red blood cells will be transfused if hemoglobin was less than 6.5 gdl-1.During bypass, anticoagulation for extracorporeal circulation was performed using heparin 300 U/kg administered into the right atrium. Acelite activated clotting time (ACT) greater than 400 was considered adequate for commencing CPB; if less, an additional dose of 100Uof heparin will be adminstered.CPB will be conducted using nonocclusive roller pumps, arterial line filtration ,membrane oxygenators, , and blood-enriched cold hyperkalemic arrest. Systemic hypothermia documented by an esophageal temperature of 32°C will be maintained during aortic cross clamping.After completion of CPB and removal of the arterial cannula, heparin will be neutralized with 1 mg of protamine sulfate adminstered for every 100U of heparin over a period of 15 minutes . Eventually, a second dose of protamine 50 mg will be given if ACT remained above baseline. All patients will be transferred to ICU after surgery.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion and Improving Outcomes in Patients Undergoing CABG. A Prospective Randomized Trial

Actual Study Start Date :

Sep 20, 2019

Actual Primary Completion Date :

Jan 6, 2020

Actual Study Completion Date :

Jan 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: iron therapy group Apatients (n= 40) received single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg.	Drug: Iron Isomaltoside 1000 Apatients (n= 40) received single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg. Other Names: iron therapy
Placebo Comparator: placebo Patients in the placebo group (n=40)received as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.	Other: placebo Patients in the placebo group (n=40)received as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.

Arm

Intervention/Treatment

Active Comparator: iron therapy group

Apatients (n= 40) received single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg.

Drug: Iron Isomaltoside 1000

Apatients (n= 40) received single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg.

Other Names:

iron therapy

Placebo Comparator: placebo

Patients in the placebo group (n=40)received as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.

Other: placebo

Patients in the placebo group (n=40)received as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.

Outcome Measures

Primary Outcome Measures

haemoglobin concentration change [1 week after discharge from hospital]
the change in the Hb concentration at baseline, intraoperative, at discharge and 1 week after discharge in non-anaemic patients undergoing cardiac surgery.

Secondary Outcome Measures

hospital stay [7 to 10 days]
duration of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

52 Years to 73 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients aged 52-73 years old
ASA II/III
elective CABG
hemoglobin level at baseline for males >13.0 g/dl and for females >12.0 g/dl.

Exclusion Criteria:

Patients with known hypersensitivity to iron sucrose
history of hepatitis B or C or human immunodeficiency virus
folate or vitamin B12deficiency, history of unstable angina,
active severe infection
suspicion of iron overload (ferritin > 300 μg/l ), or autologous blood transfusion in the previous month pregnancy and nursing impaired renal function defined by s-creatinine >150 μmol/L patients received any iron preparations in the previous month

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams university	Cairo		Egypt	11566

Sponsors and Collaborators

Ain Shams University

Investigators

Study Director: Ayman Shoeb, professor, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoda Shokri, Associate professor of Anesthesia, Ain Shams University

ClinicalTrials.gov Identifier:

NCT04061655

Other Study ID Numbers:

FMASU R 03/ 2019

First Posted:

Aug 20, 2019

Last Update Posted:

Jan 22, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hoda Shokri, Associate professor of Anesthesia, Ain Shams University

CABG

iron therapy

blood transfusion

Additional relevant MeSH terms:

Iron

Iron isomaltoside 1000

Study Results

No Results Posted as of Jan 22, 2020