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Trial Detail

CUHK_CCRB00612

2018-06-26

Prospective

2018.128-T

Prince of Wales Hospital, Hospital Authority

Department of Anaesthesia and Intensive Care, PWH

Department of Surgery, PWH

Form a group with the primary sponsor in which the responsibilities of sponsorship are allocated among the members of the group

Dr. FUNG Pui Lam Polly

Department of Anaesthesia and Intensive Care,
4/F, Prince of Wales Hospital,
Shatin, N.T.
Hong Kong

55699557

pollyfungfpl@gmail.com

Resident, Department of Anaesthesia and Intensive Care, PWH

Hong Kong

Pui Lam Polly Fung

Department of Anaesthesia and Intensive Care,
4/F, Prince of Wales Hospital,
Shatin, N.T.
Hong Kong

55699557

pollyfungfpl@gmail.com

Department of Anaesthesia and Intensive Care, Prince of Wales Hospital

Hong Kong

Efficacy of preoperative intravenous iron isomaltoside in colorectal cancer surgical patients with iron deficiency anaemia compared to standard care: a pilot randomized controlled trial

Efficacy of preoperative intravenous iron isomaltoside in colorectal cancer surgical patients with iron deficiency anaemia compared to standard care: a pilot randomized controlled trial

為大腸癌病人在手術前給予經靜脈注射鐵質補充劑(Iron isomaltoside)的效能 – 先導隨機對照試驗

Hong Kong

Yes

2018-04-26

Joint CUHK-NTEC Clinical Research Ethics Committee

2018.128-T

Iron deficiency anaemia

Colorectal cancer

Drug

Iron Isomaltoside 1000 Inj. (100mg/ml and 500mg/5mls)

Intravenous infusion

20mg/kg (<50kg BW) or 1000mg (>50kg BW)

single +/- second dose 2 weeks later (in time frame of 3-10 weeks before operation)

single +/- second dose 2 weeks later (in time frame of 3-10 weeks before operation)

Standard care(control) - no iron supplement

N/A

N/A

N/A

N/A

Age >18 years old with written informed consent

Anaemia defined as: hemoglobin concentration < 13g/dL

Laboratory test confirmed iron deficiency: serum ferritin <30mcg/L alone or serum ferritin 30-100mcg/L with TSAT < 20%

Pregnancy or lactation

Other known causes of anaemia apart from iron deficiency: untreated B12/folate deficiency, hemolytic disease, hemoglobinopathy/thalassemia, chronic renal failure on dialysis

Presence of iron overload (serum ferritin > 300g/dL or TSAT > 50%); known hemochromatosis

Previous or ongoing iron replacement/use of erythropoietin within 12 weeks before recruitment

Known hypersensitivity towards iron isomaltoside

Significant liver function derangement (AST/ALP exceeding three times upper limit of normal range)

Use of preoperative immunosuppressant therapy

Participation in another ongoing interventional clinical trial(s)

Patients with less than 3 weeks waiting time to surgery

18

999

Both Male and Female

Interventional

Randomized

1:1 allocation, treatment allocation will be concealed in sealed opaque envelopes

Not Applicable

Single-blind

Investigator/research team

Parallel

3

2018-07-02

40

Complete

Preoperative change in hemoglobin concentration

g/dL

difference between the value at diagnosis(baseline) and preoperative day (3-10weeks after diagnosis)

Preoperative change in serum ferritin

mcg/L

difference between the value at diagnosis(baseline) and preoperative day (3-10weeks after diagnosis)

Units of red blood cells transfused in perioperative period

Unit(s)

Units of red blood cells transfused from diagnosis to discharge(3-12weeks)

Duration of hospital stay

day(s)

1 days up to 1 month

Quality of recovery as measured by questionnaire (QoR-15(Chinese)

0-150

post op day 3

Incidence of adverse reactions/serious adverse events to intravenous iron administration and adverse reaction to blood transfusions

N/A

up to post op day 30

Rate of surgical complications

recorded and graded according to Clavien Classification of Surgical Complications

up to post op day 30

Days (alive and) at home within 30 days of surgery (DAH30)

day(s)

up to post op day 30

No

2020-09-04

ChiCTR1800017010

2018-06-26

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