OBJECTIVE: Bleeding and vascular access site complications are an important cause of morbidity after percutaneous femoral procedures. New haemostatic dressings have been developed to control heavy bleeding. To evaluate the efficacy of a new kaolin-based haemostatic bandage for femoral artery closure after diagnostic or interventional procedures compared with manual compression. METHODS: The first pilot European trial using this haemostatic bandage was performed at the in Milan, Italy. Two-hundred patients (71% male, mean age 66 ± 11 years) undergoing angiography or PCI via a femoral approach were randomised to the haemostatic bandage (n = 100) or manual compression (n = 100) following sheath removal. The mean active clotting time (ACT) at haemostasis was 146 ± 24 s (range 98-198 s). Haemostasis was achieved in 5.4 ± 1.5 min with the bandage vs 25 ± 15 min after manual compression, p < 0.001. No haemostasis failure occurred in either group. No differences in oozing, minor and major haematomas and pseudoaneurysms were observed. All patients ambulated at 4 h. Major bleeding, re-bleeding or haematoma did not occur after early (4 h after the procedure) ambulation following use of the bandage. CONCLUSIONS: The haemostatic bandage obtained prompt and significantly shorter haemostasis than controls. This novel haemostatic device allowed for early ambulation without clinical complications.
RCT Entities:
OBJECTIVE:Bleeding and vascular access site complications are an important cause of morbidity after percutaneous femoral procedures. New haemostatic dressings have been developed to control heavy bleeding. To evaluate the efficacy of a new kaolin-based haemostatic bandage for femoral artery closure after diagnostic or interventional procedures compared with manual compression. METHODS: The first pilot European trial using this haemostatic bandage was performed at the in Milan, Italy. Two-hundred patients (71% male, mean age 66 ± 11 years) undergoing angiography or PCI via a femoral approach were randomised to the haemostatic bandage (n = 100) or manual compression (n = 100) following sheath removal. The mean active clotting time (ACT) at haemostasis was 146 ± 24 s (range 98-198 s). Haemostasis was achieved in 5.4 ± 1.5 min with the bandage vs 25 ± 15 min after manual compression, p < 0.001. No haemostasis failure occurred in either group. No differences in oozing, minor and major haematomas and pseudoaneurysms were observed. All patients ambulated at 4 h. Majorbleeding, re-bleeding or haematoma did not occur after early (4 h after the procedure) ambulation following use of the bandage. CONCLUSIONS: The haemostatic bandage obtained prompt and significantly shorter haemostasis than controls. This novel haemostatic device allowed for early ambulation without clinical complications.
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