Randomised control trial
Biggs J.C, Hugh T.B, Dodds A.JTranexamic acid and upper gatrointestinal haemorrhage - a double blind study
Gut
1976, 17, 729-734
- 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: efficacy of antifibrinolytic therapy in patients with acute upper gastrointestinal haemorrhage in terms of transfusion requirements, surgical intervention, side effects and death.
2
Design
2.1
Is the study design suitable for the objectives
Yes - randomised controlled trial.
2.2
Who / what was studied?
Patients presenting to the Accident and Emergency Department with upper gastronintestinal blood loss as identified by visualisation of haematemesis or malaena, or on lavage.
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 estimate made
2.5
Were all subjects accounted for?
Impression that no withdrawals or dropouts occurred, but this was not specifically reported
2.6
Were all appropriate outcomes considered?
Yes
2.7
Has ethical approval been obtained if appropriate?
Not commented upon
2.8
Were the patients randomised between treatments?
Yes
2.9
How was randomisation carried out?
It is not stated in the paper.
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?
It is stated that they were.
4
Presentation of results
4.1
Are the basic data adequately described?
Yes.
4.2
Were groups comparable at baseline?
Yes, largely so, although more patients had consumed alcohol in the placebo group. This is not commented upon further.
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?
Reports that there were no major side effects of therapy. Does not specifically comment on thromboembolic events.
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?
Yes - indicates that tranexamic acid results in reduced levels of surgical intervention.
7.2
What level of evidence has this paper presented? (using CEBM levels)
1b
7.3
Does this paper help me answer my problem?
It indicates that there may be a reduction in the amount of surgery required for patients in the tranexamic acid group. There is limited external validity due to the date of publication.
8
Implementation
8.1
Can any necessary change be implemented in practice?
No.
8.2
What aids to implementation exist?
Not applicable
8.3
What barriers to implementation exist?
Not applicable