Why the study?
Does the Simplate II bleeding time device provide comparable bleeding times to the Mielke Template in healthy volunteers and patients?
Does the Simplate II bleeding time device provide comparable bleeding times to the Mielke Template in healthy volunteers and patients?
The Simplate II device provides comparable bleeding times to the Mielke Template while being simpler and more rapid to use.
Simplate II may substitute for Mielke Template in bleeding time testing; confirms device equivalence in this Level 3 trial but leaves standardization open.
The authors report a clinical trial comparing a new bleeding time device (Simplate II) with the Mielke Template. Bleeding times were determined at the same time on the same arm using the two devices. Subjects of the study were 24 healthy volunteers, before and two hours after ingestion of 975 mg aspirin, and 28 patients. For the normal subjects the mean pre-aspirin bleeding times were 4.75 +/- 1.42 minutes (1 SD) with the Simplate II and 3.65 +/- 1.22 minutes with the Mielke Template. The mean bleeding times two hours after ingestion of aspirin were 7.86 +/- 2.76 minutes with the Simplate II and 7.84 +/- 2.94 minutes with the Template. The pre- and the post-aspirin values with the two devices were not significantly different from each other, nor were the bleeding times obtained in the patients with the two devices. The extents of scarring were similar with the two devices. The results were highly reproducible by both methods. The new device was simpler and more rapid to use.
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Kumar et al. (1978) studied this question.
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