Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00612

2 Trial Registration Date

2018-06-26

i Registration Status

Prospective

3 Secondary IDs

2018.128-T

4 Source(s) of Funding

Prince of Wales Hospital, Hospital Authority

5 Primary Sponsor

Department of Anaesthesia and Intensive Care, PWH

6 Secondary Sponsor

Department of Surgery, PWH

Function

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

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr. FUNG Pui Lam Polly

ii Address

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

iii Phone

55699557

iv Email

pollyfungfpl@gmail.com

v Affiliation

Resident, Department of Anaesthesia and Intensive Care, PWH

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Pui Lam Polly Fung

ii Address

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

iii Phone

55699557

iv Email

pollyfungfpl@gmail.com

v Affiliation

Department of Anaesthesia and Intensive Care, Prince of Wales Hospital

vi Country

Hong Kong

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-04-26

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.128-T

14 Medical Condition Being Studied

Iron deficiency anaemia

Colorectal cancer

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

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

iii Dosage form of the intervention

Intravenous infusion

iv Dosage of the intervention

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

v Duration of the intervention

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

vi Frequency of the intervention

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

16 Comparative Treatments

i Description/ name of comparative treatments

Standard care(control) - no iron supplement

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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%

ii Exclusion Criteria

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

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

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

ii Nature of control

Not Applicable

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

3

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-07-02

21 Target Sample Size

40

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Preoperative change in hemoglobin concentration

ii The metric or method of measurement used

g/dL

iii The timepoint(s) of primary interest

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

Primary Outcome

i The Name of the outcome

Preoperative change in serum ferritin

ii The metric or method of measurement used

mcg/L

iii The timepoint(s) of primary interest

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

24 Secondary Outcome

i The Name of the outcome

Units of red blood cells transfused in perioperative period

ii The metric or method of measurement used

Unit(s)

iii The timepoint(s) of primary interest

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

Secondary Outcome

i The Name of the outcome

Duration of hospital stay

ii The metric or method of measurement used

day(s)

iii The timepoint(s) of primary interest

1 days up to 1 month

Secondary Outcome

i The Name of the outcome

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

ii The metric or method of measurement used

0-150

iii The timepoint(s) of primary interest

post op day 3

Secondary Outcome

i The Name of the outcome

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

ii The metric or method of measurement used

N/A

iii The timepoint(s) of primary interest

up to post op day 30

Secondary Outcome

i The Name of the outcome

Rate of surgical complications

ii The metric or method of measurement used

recorded and graded according to Clavien Classification of Surgical Complications

iii The timepoint(s) of primary interest

up to post op day 30

Secondary Outcome

i The Name of the outcome

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

ii The metric or method of measurement used

day(s)

iii The timepoint(s) of primary interest

up to post op day 30

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-09-04

27 Primary Registry and Trial Identifying Number

ChiCTR1800017010

28 Date of Registration in Primary Registry

2018-06-26

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Trial History Detail on 2018-09-04