Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion

NCT04061655 | Completed Early Phase 1

• 1 other identifier: FMASU R 03/ 2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications

Keywords

CABG; iron therapy; blood transfusion

Outcome Measures

Primary Outcomes (1)

• haemoglobin concentration change

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

  1 week after discharge from hospital

Secondary Outcomes (1)

• hospital stay

  7 to 10 days

Study Arms (2)

iron therapy group

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

Iron Isomaltoside 1000 DRUG

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.

Also known as: iron therapy

iron therapy group

placebo OTHER

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.

placebo

Eligibility Criteria

• Age: 52 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, 11566, Egypt

Location

MeSH Terms

Interventions

iron isomaltoside 1000

Study Officials

• Ayman Shoeb, professor

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Anesthesia

Study Record Dates

• First Submitted: August 17, 2019
• First Posted: August 20, 2019
• Study Start: September 20, 2019
• Primary Completion: January 6, 2020
• Study Completion: January 10, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months
• Access Criteria: Descriptive statistics will be carried out for numerical parametric data and presented as mean±SD, whereas categorical data will be presented as number and percentage. Variables such as demographic data and comorbidities will be compared using the χ2-test

Locations

EG (1)