Randomised control trial
von Holstein CC, Ericksson SB, Kallen R.Tranexamic acid as an aid to reducing blood transfusion requirements in gastric and duodenal bleeding.
BMJ
1987; 294: 7-10
- Submitted by:Anna Morgan - ST6 Emergency Medicine
- Institution:Homerton Hospital
- Date submitted:19th May 2011
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes: prospective double blind randomised control trial examining the effects of tranexamic acid compared with placebo in patietns with bleeding from verified benign lesions in the stomach or duodenum or both. Outcomes: blood transfusion, rebleeding episodes and urgent need for surgery.
2
Design
2.1
Is the study design suitable for the objectives
Yes: randomised double blind control study
2.2
Who / what was studied?
Patients presenting with bleeding verified to be from a benign source in the stomach or duodenum or both.
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?
Yes - sample size estimates and power calculated.
2.5
Were all subjects accounted for?
Yes, all patients withdrawn from the study detailed
2.6
Were all appropriate outcomes considered?
Mortality was not detailed as an outcome
2.7
Has ethical approval been obtained if appropriate?
Not detailed
2.8
Were the patients randomised between treatments?
Yes
2.9
How was randomisation carried out?
In batches of 10, valdidity of method questionable
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?
Yes
4
Presentation of results
4.1
Are the basic data adequately described?
Yes
4.2
Were groups comparable at baseline?
Yes, fully detailed
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?
Yes
7.2
What level of evidence has this paper presented? (using CEBM levels)
1b - randomised control trial
7.3
Does this paper help me answer my problem?
Yes - indicates that in patients with massive gastrointestinal bleeding tranexamic acid can reduce transfusion requirements and need for emergency surgery
8
Implementation
8.1
Can any necessary change be implemented in practice?
External validity: Considering the changes in medical practice since the date of this trial mean that implementation of changes in practice cannot be determined from this evidence alone.
8.2
What aids to implementation exist?
Not applicable
8.3
What barriers to implementation exist?
Not applicable