Randomised control trial
Cormack F, Chakrabarti RR, Jouhar AJ et alTranexamic Acid In Upper Gastrointestinal Haemorrage
The Lancet
1973, 1: 1207-1208
- Submitted by:Anna Morgan - ST6 Emergency Medicine
- Institution:Homerton Hospital
- Date submitted:17th May 2011
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes, to evaluate the effectiveness of tranexamic acid in patients with upper gastrointestinal bleeding.
2
Design
2.1
Is the study design suitable for the objectives
Yes, it is a randomised double-blind trial.
2.2
Who / what was studied?
150 patients who presented with frank haemetemesis or melena. Randomised to either receive either 1.5g of tranexamic acid eight hourly for seven days or placebo.
2.3
Was this the right sample to answer the objectives?
Yes
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
No sample size calculation was made and the study may have been to small to achieve its objectives.
2.5
Were all subjects accounted for?
No dropouts were mentioned.
2.6
Were all appropriate outcomes considered?
Yes
2.7
Has ethical approval been obtained if appropriate?
Not commented on
2.8
Were the patients randomised between treatments?
Yes
2.9
How was randomisation carried out?
No information is given on how randomisation was performed.
2.10
Are the outcomes clinically relevant?
Yes, transfusion requirements, death, need for surgery, continued or recurrent bleeding.
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes
3.2
Are the measurements valid?
Yes
3.3
Are the measurements reliable?
Yes - but all combined together
3.4
Are the measurements reproducible?
Yes
3.5
Were the patients and the investigators blinded?
Yes
4
Presentation of results
4.1
Are the basic data adequately described?
Yes
4.2
Were groups comparable at baseline?
More in poor condition in the control group than in the treatment group.
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Yes
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes
4.5
Were side effects reported?
Yes
5
Analysis
5.1
Are the data suitable for analysis?
Yes
5.2
Are the methods appropriate to the data?
Yes
5.3
Are any statistics correctly performed and interpreted?
Yes
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes
6.2
Is the discussion biased?
No
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
The authors conclude that the study suggests that tranexamic acid favourably influenced bleeding caused by peptic ulceration or eroision, this is based on an ad hoc subgroup analysis of their data and as such looses validity.
7.2
What level of evidence has this paper presented? (using CEBM levels)
1b
7.3
Does this paper help me answer my problem?
No, The paper has limited external validity as the treatment of patients with upper gastrointestinal intestinal bleeding has changed since the time of the study. It does not provide evidence of tranexamic acid improving outcomes in patients with upper gastrointestinal bleeding but may be underpowered to do so.
8
Implementation
8.1
Can any necessary change be implemented in practice?
8.2
What aids to implementation exist?
8.3
What barriers to implementation exist?