Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00399

2 Trial Registration Date

2014-03-27

i Registration Status

Prospective

3 Secondary IDs

CRE 2013.644-T

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

Dr KW Cheung

6 Secondary Sponsor

Prof. Kevin KW Ho

Function

Please specify

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

i Name

JoJo Kwok

ii Address

Department of Orthopaedics and Traumatoloy, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

26326553

iv Email

jojokwok@cuhk.edu.hk

v Affiliation

Department of Orthopaedics and Traumatoloy, The Chinese University of Hong Kong

vi Country

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

i Name

Dr KW Cheung

ii Address

Department of Orthopaedics and Traumatoloy, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT Hong Kong, SAR

iii Phone

26321817

iv Email

kwcheung@ort.cuhk.edu.hk

v Affiliation

Department of Orthopaedics and Traumatoloy, Prince of Wales Hospital

vi Country

9 Official Scientific Title of the Study

Intra-articular VS Intravenous Tranexamic Acid in Total Knee Arthroplasty – A Randomized Controlled Trial Comparing Effectiveness and Safety

10 Public Title

Intra-articular VS Intravenous Tranexamic Acid in Total Knee Arthroplasty

i Public Title in Chinese 研究名稱

臨床研究 –「全膝關節置換手術：止血劑的成效與應用」

11 Short Title (Optional)

Intra-articular VS Intravenous Tranexamic Acid in Total Knee Arthroplasty

12 Countries of Recruitment

HKSAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-01-16

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Knee Osteoarthritis

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Tranexamic acid

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

During the operation

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

To compare the blood-saving effects and risks of developing symptomatic thromboembolic events after total knee arthroplasty by using intra-articular and intravenous tranexamic acid

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusive criteria are subjects with degenerative osteoarthritis of knee joints, who are scheduled for TKA with posterior stabilized total knee prosthesis.

ii Exclusion Criteria

Exclusion criteria are patients with pre-operative anemia with haemoglobin level less than 12 g/dL (reference of PWH lab), known allergy to TNA, deep vein thrombosis, pulmonary embolism, ischemic stroke, those on anticoagulant drugs including warfarin and Plavix, or those undergo TKA under epidural anesthesia, those with renal impairment(with creatinine level >200) and inflammatory arthritic patient.

iii Age Minimum

18

iv Age Maximum

100

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Dose comparison

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-03-28

21 Target Sample Size

150

22 Recruitment Status

Recruiting

23 Primary Outcome

Blood loss after operation, based on the change in haemoglobin level, drain output and wound discharge at baseline and post-operation day 5; any symptomatic thromboembolic events after operation at post-operation day 5

24 Secondary Outcome

Length of stay in hospital

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-30

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004440

28 Date of Registration in Primary Registry

2014-03-29

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-04-07