Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00394

2 Trial Registration Date

2014-02-05

iRegistration Status

Prospective

3 Secondary IDs

CRE-2013.666-T

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

Department of Anaesthesia & Intensive Care, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Simon Chan

ii Address

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

(852)2632 2734

iv Email

simonkcchan@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

vi Country

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

i Name

Ms Winnie Samy

ii Address

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

(852)2632 2735

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

vi Country

9 Official Scientific Title of the Study

A randomized-control multi-centres study on the safety & effectiveness of peri-operative transfusion trigger score (POTTS)

10 Public Title

A randomized-control multi-centres study on the safety & effectiveness of peri-operative transfusion trigger score (POTTS)

i Public Title in Chinese 研究名稱

圍手術期輸血指征評分（Peri-Operative Transfusion Trigger Score, POTTS）安全性與有效性的多中心，隨機，對照臨床研究

11 Short Title (Optional)

RCT on POTTS

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-01-27

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Elective surgery with potential massive blood loss requiring blood transfusion

15Intervention

i Types of intervention

Other

Please specify

Decision on blood transfusion

ii Description/ name of Intervention/article

The decision on blood transfusion will be in accordance on the POTTS scoring system based on: inotrope requirement, oxygen requirement, body temperature and history of coronary artery disease.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Intra-operative and post-operative period.

vi Frequency of the intervention

16Comparative Treatments

i Description/ name of comparative treatments

Elective surgical patients will be randomized to 3 groups:
1. transfusion to keep Hb > 10g/dL ,
2. transfusion based on clinicians' discretion when Hb between 7-10g/dL; and
3. POTTS group.

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

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Age≥14 weeks old
2. Live in an area of altitude < 2500 m most of the time
3. Estimated intraoperative blood loss >1000ml, or > 20% of total blood volume

ii Exclusion Criteria

1 Emergency surgery
2 Patients with physical status of ASA class V or above
3 Patients with known severe haematological disorders
4 Patients with known haemaglobinopathy
5 Acute hypervolemic haemodilution is planned.
6 Patients with known metastatic cancer or more than one neoplasm concurrently.
7 Other conditions that may preclude the patients from the study, such as language barrier, psychiatric disorders, unable to attend research center for follow up.
8 Patients who enrolled to another research study or are taking experimental medication in last 3 months prior to this study.
9 Not suitable for the study, after assessment by the investigators

iii Age Minimum

14 weeks old

iv Age Maximum

nil

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-02-20

21 Target Sample Size

20

22 Recruitment Status

Recruiting

23 Primary Outcome

1 Incidence of patients required blood transfusion and the unit number of blood transfused.
2 Mortality rate and incidence of serious complications.
3 Five-year in remission survival rate after hospital discharge and overall survival rate.

24 Secondary Outcome

1 Intensive Care Unit (ICU) admission rate and ICU length of stay (LOS)
2 Post-operative Hb level
3 Surgical wound complication rate
4 Hospital length of stay
5 Transfusion-related cost and hospital admission cost
6 Post-operative quality of life

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2015-12-27

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004478

28 Date of Registration in Primary Registry

2014-04-10

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-11-27