The aim of this study is describe pain (score 1-10) and discomfort (scale 1-5) of the 1 hour protocol of R band with Statseal and retrospective of a 2 hour protocol of R band during the R-band and the out-patient department. Secundary purpose:…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
nazorg na hartcatheterisatie en percutaan coronair interventie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Occlusion: will be measured using a mobile Doppler ultrasound device. This will
be done after removing the R band and when the patient is visiting the
out-patient department.
the primary study parameter discomfort: will be described and measured on a
scale from 1 to 5 (5 serious, 4 considerable, 3 moderate, 2 a little,1 no
discomfort) at arrival on the CCU/CL after CAG/PCI, after removing the R band
and during the out patient department visit.
Secondary outcome
Bleeding complication: bleeding complication is defined as signs of bleeding
from the radial artery where medical intervention is directly needed. Medical
intervention of a R band or reapplication of the R band as a result of bleeding
after earlier deflation according to the protocol or a decline in Hb of more
than 3 g/dl from a hematoma of more than 5 cm will be seen as a complication.
Pain: pain will be measured using the Visual analogue scale from 1-10 at
arrival on the CCU/CL after CAG/PCI, after removing the R band and on the firts
out-patient department visit.
Discomfort: will be measured on a scale from 1 to 5 (5 serious, 4 considerable,
3 moderate, 2 a little,1 no discomfort) at arrival on the CCU/CL after CAG/PCI,
after removing the R band and on the firts out-patient department visit.
Duration hospital stay: will be measured in minutes from the moment the R band
is placed after a CAG/PCI until discharge from the hospital.
Use of number of different coagulantia: the total number of different
coagulantia will noted before CAG/PCI until the last follow up control (on the
firts out-patient department visit)
Costs used material for radial artery compression: the number of used R bands
and/or Staseal will be registered. The purchase price, inclusive sales tax, of
the R band and Statseal will be collected and added up toghether.
Costs complication treatment: all used material, bloodproducts, medication,
consultation, possible surgical intervention and diagnostic examination to
investigate or treat the complication of the radial artery compression will be
collected from Hix and calculated, inclusive sales tax.
Background summary
The radial artery is the preferential access route for diagnostic coronary
angiography and percutaneaous coronary intervention. More than 60% of the
patients undergo a transradial procedure. Hemostasis could be achieved by
compression, manually or through a device. Usually this is achieved by placing
a radial band for compression of the radial artery.
The transradial approach gives less access side bleedings, less discomfort and
short hospital stay when this is compared to the femoral access. However, the
incidence for radial artery occlusion is 2%-10%. Pancholy (1) proved that the
shortened compression duration can lead to a less risk on radial artery
occlusion. Dueling (2) and Carrington (3) proved in a study that a shortened
compression duration through the Terumo band is not accompanied by an elevation
of bleeding complications and this shortening can be accompanied by less
complaints and an potentially shorter hospital stay. The duration of
compression through the radial band is not uniformally described. The aim of
this study is discribe the experience of the patient, with a pain and
discomfort score of the one hour protocol with Statseal and of a 2 hour
protocol of the R band, for the duration of the R band and after visiting the
out-patient departement. we also like to describe occlusions of the radial
artery, bleeding complications, hematoma of more than 5 cm and
cost-effectiveness.
Study objective
The aim of this study is describe pain (score 1-10) and discomfort (scale 1-5)
of the 1 hour protocol of R band with Statseal and retrospective of a 2 hour
protocol of R band during the R-band and the out-patient department.
Secundary purpose:
Describe the bleeding complications of the radial artery, hematoma of more then
5 cm and the need to use bloodproducts of an 1 hour protocol with R-band with
Statseal and a 2 hour protocol of R-band.
To describe the difference in cost-effectiveness on hopsital stay and material
costs when an 1 hour protocol of R band with Statseal is compared to the 2 hour
protocol of R band
Study design
It is a prospective, single center, only blind, not randomized cohort to
describe pain and discomfort of an 1 hour protocol of R band with Statseal for
the duration of the R band and on the out patient department. Retrospective
data will be used of the 2 hour protocol of R band .
Intervention
The research treatment concerns the duration of R band with StatSeal after a
coronary angiography and/or percutaneous coronary intervention, the 2 hour
protocol of R band is the standard protocol and the 1 hour protocol of R band
with Statseal the experimental group in our medical center.
Study burden and risks
This study does not involve any other risk or complication for the patient.
Els Borst-Eilersplein 275
Den Haag 2545 AA
NL
Els Borst-Eilersplein 275
Den Haag 2545 AA
NL
Listed location countries
Age
Inclusion criteria
the subject is 18 years or older
the subject has given informed consent
the subject is planned for a diagnostic coronair angiography and/or (planned or acute or urgent) percutaneous coronair intervention
Exclusion criteria
the subject has received Rheopro or bivaluridin iv during the CAG/PCI
the coronair angiography and/or percutaneous coronair intervention isn't performed through the artery radialis;the subject has a AV shunt for kidneydialysis or is a candidate for this
the subject has a known pathology of artery of the upper body or subclavia
the subject is incapable
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL65691.098.18 |
| OMON | NL-OMON20172 |