The use of the D-STAT dry bandage for the control of vascular access site bleeding: a multicenter experience in 376 patients

Multiple topical hemostats have been approved for control of surface bleeding from vascular access sites. The majority of these devices, however, have few clinical data supporting their use. This study was conducted to assess the efficacy and safety of the new commercially available D-Stat Dry hemos...

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Bibliographic Details
Published in:Cardiovascular and interventional radiology 2007-07, Vol.30 (4), p.593-600
Main Authors: Hallak, Omar K, Cubeddu, Roberto J, Griffith, Rose A, Reyes, Bernardo J
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Angiography - methods
ARTERIES
Bandages
BIOMEDICAL RADIOGRAPHY
BLOOD FLOW
Cardiac Catheterization - methods
COMPRESSION
Early Ambulation
Female
Femoral Artery - surgery
Hemostasis, Surgical - methods
Hemostatics - administration & dosage
Humans
Male
Middle Aged
Patient Satisfaction
PATIENTS
Pressure
Prospective Studies
Punctures
RADIOLOGY AND NUCLEAR MEDICINE
VASCULAR DISEASES
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Summary:Multiple topical hemostats have been approved for control of surface bleeding from vascular access sites. The majority of these devices, however, have few clinical data supporting their use. This study was conducted to assess the efficacy and safety of the new commercially available D-Stat Dry hemostatic bandage compared to standard care manual compression. A prospective, randomized, multicenter trial was conducted in patients undergoing diagnostic cardiac catheterization or peripheral angiography utilizing femoral artery access. Subjects were randomized to either the D-Stat Dry bandage as an adjunct to manual compression or manual compression alone. Primary end points were time-to-hemostasis (TTH) and major complications. Secondary end points included minor complications, patient satisfaction, time-to-ambulation (TTA), and time-to-discharge (TTD). Three hundred seventy-six subjects (189 control, 187 investigational) with similar baseline characteristics participated in the study. The mean age was 61.5 years, with a male predominance of 58%. TTH was significantly lower in the investigational group (7.8 vs. 13.0 min; p = 0.001). No difference in major complication rates was observed between the groups. The mean TTA (investigational, 392 min, vs. control, 415 min; p = 0.023) and patient satisfaction significantly favored the investigational group (p = 0.025). No difference in TTD or the rate of minor complications was observed. This study demonstrates that in the aforementioned population, the D-Stat Dry bandage is safe and effective in reducing both TTH and TTA and results in improved patient satisfaction.
ISSN:0174-1551
1432-086X
DOI:10.1007/s00270-007-9019-4