Randomised control trial
Engqvist A, Brostrom O, von Feilitzen F, et al.Tranexamic acid in massive haemorrhage from the upper gastrointestinal tract: a double blind study
Scand J Gastroenterol
1979; 14: 839-44
- Submitted by:Anna Morgan - ST6 Emergency Medicine
- Institution:Homerton Hospital
- Date submitted:15th May 2011
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes: double blind trial of tranexamic acid versus placebo in massive gastrointestinal haemorrhage (defined as haematemesis or melaena with circulatory embarrassment) in terms of transfusion requirements, recurrent and continued bleeding, surgery and mortality.
2
Design
2.1
Is the study design suitable for the objectives
Yes
2.2
Who / what was studied?
Patients presenting with massive gastrointestinal haemorrhage (defined as haematemesis or melaena with circulatory embarrassment) to ITU.
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?
Not discussed
2.5
Were all subjects accounted for?
Yes
2.6
Were all appropriate outcomes considered?
Yes
2.7
Has ethical approval been obtained if appropriate?
Not specified
2.8
Were the patients randomised between treatments?
Yes
2.9
How was randomisation carried out?
Not specified
2.10
Are the outcomes clinically relevant?
Yes
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
3.4
Are the measurements reproducible?
Yes
3.5
Were the patients and the investigators blinded?
States that they were
4
Presentation of results
4.1
Are the basic data adequately described?
Yes
4.2
Were groups comparable at baseline?
Yes
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
No- transfusion data lacks clarity and evidence of statistical analysis.
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes
4.5
Were side effects reported?
Yes - thromoembolic events detailed
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?
May overstate the effects of tranexamic acid on their population
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
Difference in transfusion requirements between the two groups is statistically significant, but small nonetheless, this may be overstated in the conlusions of the paper, espcially in view of the side effet profile.
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 - indicates that there may be a reduction in transfusion requirements with the use of tranexamic acid.
8
Implementation
8.1
Can any necessary change be implemented in practice?
No - external validity issues regarding how applicable the information is in view of changing clinical practice since the time of the study.
8.2
What aids to implementation exist?
Not applicable
8.3
What barriers to implementation exist?
Not applicable