Cardiac Catheterisation Clinical Trial
Official title:
Shortening Compression Time of the Access Site After Cardiac Catheterisation Through the Radial Artery
To obtain arterial access for a diagnostic cardiac catheterization or percutaneous coronary
intervention (PCI) the cardiologist can choose between the femoral artery and the radial
artery. In the University Medical Center Groningen the femoral artery is commonly used.
After intervention the puncture site is closed with an arteriotomy closure device (ACD).
Patients after radial access receive a pressure bandage at the puncture site, usually the
Terumo (TR) wrist bandage.
The bedrest period for patients with an ACD is 1 hour after diagnostic cardiac
catheterization and 2 hours after PCI. After the bedrest period patients are discharged 1
hour after diagnostic procedures or 4 hours after PCI. This to observe potential bleeding
complications after the procedure. In patients with radial access, the TR bandage will be
removed according to current protocol after 4 hours and additionally 1 hour observation is
required. Several cardiologists have the intention to use the radial artery more frequent
for cardiac catheterization or PCI. In a meta-analysis radial access is related to a 73%
decrease in major bleeding complications compared to femoral access. Also there are no
significant differences in MACE. Even so there are no differences in success percentage for
cardiac catheterization or PCI and admission time is shorter for radial access (Am Heart J.
2009 Jan;157(1):132- 40). Admission time for diagnostic cardiac catheterization at the
short-stay unit is in case of femoral access with an ACD approximately 2 hours. For patients
after radial access post procedural admission time is approximately 5 hours. To guarantee
patient throughput, uniformity of care and more efficient use of capacity of the short-stay
unit, patients after radial access should not have a longer hospital admission time than
patients after femoral access. Carrington et al. (J Interv Cardiol. 2009 Dec;22(6):571-5)
have shown that it is safe to deflate the TR wrist band faster than four hours.
Objective of the study:
To describe the differences in safety, patient comfort and admission period after diagnostic
cardiac catheterization through radial access, between the current protocol and the protocol
of fast desufflation by Carrington et al.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02343276 -
Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs
|
Phase 3 |