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DALI 500 / 750 ADSORBER
en
CONTRAINDICATIONS
Product-specific contraindications
−
Patients who currently take Angiotensin Converting Enzyme (ACE) inhibitors (e.g.
enalapril, ramipril, lisinopril, etc.), as well as combination drugs which contain ACE
inhibitors, or other drugs which influence the regulation of bradykinin (e.g. Angiotensin-
Receptor-Neprilysin-Inhibitors).
−
Patients who suffer from thrombocytopenia (<40 x 10
−
Patients
with
known
hypersensitivity
DALI 500 / 750 Adsorbers.
−
Patients who suffer from: acute systemic infection, acute cold or influenza infections
and/or severe acute cardiovascular diseases which forbid any extracorporeal therapy like
DALI.
Treatment-related contraindications
−
Patients who are not able to tolerate the stress of an extracorporeal treatment due to
their physical status or their clinical condition.
−
Patients with a history of severe coagulopathy issues such as thrombosis or hemorrhagic
diathesis, are predisposed to an increased risk of bleeding potentially caused by the
extracorporeal apheresis procedure and the accompanying anticoagulation.
−
Patients in whom adequate anticoagulation cannot be achieved (e.g. due reduced citrate
metabolism, HIT-II).
Relative treatment-related contraindications
(require a particularly careful benefit-risk evaluation before the application of apheresis):
−
Patients who suffer from clinically relevant hypotension where any further drop in blood
pressure may be harmful.
−
Patients with impaired kidney function and reduced cardiac capacity, who may react
sensitively to acute fluid and electrolyte shifts.
−
Patients with confirmed or assumed intracranial disease in whom a fluid imbalance or
changes in blood pressure should be avoided.
−
Patients with bleeding tendency that has not been clarified.
−
Patients tending to hypocalcemia due to a concomitant disease.
Note
Additional contraindications might apply with other devices used in the therapy. Please
observe the Instructions for Use enclosed with the active device, tubings and solutions, etc.
PERFORMANCE CHARACTERISTICS
Performance data depend on the system configuration used. Several studies evaluating the
performance of the DALI Adsorbers have demonstrated mean relative reduction values, e.g.
70 % for LDL-c, 65 % for Lp(a) and 15 % for HDL-c. These levels were obtained with the
treatment system following the physician's prescription.
Please note that, besides the chosen treatment configuration, the actual reduction values also
depend on the patient's blood composition, clinical settings (refer also to paragraph
"Limitations of the medical device") as well as on the measurement method. For the treatment,
consider that a rebound effect will occur after treatment due to the underlying hyperlipidemia.
Interactions
The DALI apheresis may alter the blood concentration of drugs by adsorption. If medically
justifiable, the application time of concomitant drug therapy should therefore be adjusted to
the DALI therapy (e.g. administration of drugs after apheresis treatment). The type of
concomitant therapy as well as the dosage and time of drug administration must be
determined by the attending physician.
All medical devices with blood-contacting, negatively charged surfaces like
DALI 500 / 750 Adsorbers activate the bradykinin synthesis. Normally bradykinin is quickly
degraded by ACE, but if ACE inhibitors are used in a therapy, this degradation is delayed. This
may lead to increased bradykinin levels and anaphylactic reactions and even shock, which
may threaten the patient's life (see Contraindications). This also applies for other drugs, which
influence bradykinin regulation (synthesis or inhibition of metabolism). Patients who were
previously treated with an ACE inhibitor or other drugs, which influence bradykinin regulation,
must stop taking the drug early enough. In this case, the terminal half-life period of the active
pharmaceutical ingredient must be taken into account (e.g. after 5-fold half-life period, a
reduction to below 5 % residual concentration can be expected).
METHOD OF ADMINISTRATION
Before use
The adsorber must only be taken out of its individual packaging immediately prior to use.
Properly dispose of products that have not been used.
Use the adsorbers only if:
−
they are undamaged (i.e. no damage to packaging, housing incl. protective caps),
−
the label is readable and expiry date not exceeded,
−
the protective caps on the connectors have not become loose or dislodged,
−
they have reached room temperature (20 – 25°C) to avoid unnecessary cooling down of
the patient.
Anticoagulation
For the DALI treatment, citrate anticoagulation is mandatory. The ACD-A solution contains
citrate, which prevents coagulation. In addition, it prevents thrombocytes and the complement
system from being activated in the extracorporeal circuit. Any insufficient anticoagulation may
result in an increased residual blood volume in the adsorber (after reinfusion) and thrombocyte
activation. This may lead to an increased thrombocytes loss in the course of time. In case of
thrombocytes loss, consider increasing the ACD-A flow to avoid thrombocytopenia. The
anticoagulant requirements may vary with the patient's condition and treatment modality. It
has to be prescribed by the treating physician.
6
3
/μl).
to
the
materials
used
in
the
The following anticoagulation parameters are recommended:
Preparation
DALI Standard
(priming/rinsing)
ACD-A ratio 1:20
Before starting the
Initial i.v. (unfractionated) heparin bolus:
treatment
During treatment
Note: When changing the blood flow, adjust the ACD-A ratio according
to the formula above.
ACD-A ratio acc. to
If less ACD-A (ACD-A flow < 2.7 mL/min) is chosen, the initial heparin
blood flow
bolus must be increased.
* DALI Low Citrate can be chosen during preparation to mitigate hypersensitivity, especially during
first uses of DALI Adsorbers
** Set manually by user or (if available) set automatically by ACD-Automatic mode
In case of signs of hypocalcaemia symptoms:
To take countermeasures, the ACD-Automatic mode, if selected, must be switched off.
Initially, the ACD-A flow should be reduced by adapting the ACD-A flow/blood flow ratio.
Caution
The attending staff must check anticoagulation and blood flow rates at regular intervals.
The following treatment parameters are recommended:
First treatments
1
st
to 3
rd
treatment: start with low
Blood flow
rates: 20 – 30 mL/min
Depending on the patient's
response, the blood flow can be
slowly increased by 10 mL/min
every two minutes to a max.
50 mL/min.
st
Treated blood
1
treatment: 1/3 of target blood
volume
volume
nd
2
treatment: 2/3 of target blood
volume
3
rd
treatment: total target blood
volume
st
rd
Configuration
1
to 3
treatment: a single
adsorber (DALI 500 or DALI 750)
must be used.
Note
Patients may experience hypersensitivity reactions during treatment with the DALI system. The
first three treatments must be particularly monitored.
In some cases, it might be necessary to shortly interrupt the treatment if the patient shows
reactions similar to hypersensitivity when the first treated blood coming from the adsorber
returns to the patient. In this case, restart using low rates (20 – 30 mL/min) as described
above. In some patients, hypersensitivity reactions are not mitigated after restarting. In such
cases, the treatment must be terminated without returning the blood.
Patients who are excessively stressed by the blood-letting process into the extracorporeal
circuit at the start of the treatment, should be supplied with a solution for fluid volume
replacement through a venous indwelling cannula on their contralateral arm.
Blood flows below the recommended blood flow range can be set. The coagulation must be
monitored, and the decrease in clearance values might be steeper than expected.
Intended application time
In general, the duration of the treatment depends on the blood volume of the patient and the
prescription. Usually one treatment per week is carried out, resulting in approximately
50 treatments per year.
Handling
Priming and patient connection
Pretreat the adsorber with the Priming/ACD-A solution to saturate the ligand with electrolytes
and to set the pH. Add a bolus of 25,000 IU unfractionated heparin to the first primer bag.
Excess heparin is rinsed out when the 2nd primer bag is connected. To connect the adsorber
to the tubing lines, open the caps of the connectors and connect them to the corresponding
DALI tubing lines. Refer to the IFU of the active device for the detailed instruction of the set-
up. Check whether all connections have been properly established to prevent accidental
separation and leaks. Fill the adsorber with DALI Priming Solution and then close the adsorber
pressure line clamp directly at the pressure connector of the adsorber. Shake the adsorber to
achieve a homogeneous gel bed and an adequate adsorption performance. Set the level in
the drip chamber to relieve pressure from the system. Open the pressure line clamp again
and rinse the adsorber with DALI Priming Solution according to the program of the active
device, including set pump stops (flow rate: 400 mL/min; rinsing volume: 4800 mL).
Caution
Do not shake the adsorber after priming to avoid the gel bed from being disturbed and to
prevent particles from being released. Since the system is unstable both chemically and
physically, treatment must be started within 2 hours after priming. Any valid hygiene directives
of the country and/or hospital in question that specify a shorter maximum durability below 2
hours after setup must be followed. Do not rinse with physiological saline solution after priming
because, otherwise, the electrolytes may be desorbed. This would result in hypocalcemia in
the patient. A sieve is installed in the return line downstream the DALI Adsorber(s), which
serves as a second safety barrier for particles in case the housing sieve is ruptured. The same
mesh size is used as in the DALI housing, therefore particles above 40 μm are retained.
DALI Low Citrate*
or
ACD-A ratio 1:40
20 IU/kg BW
1:(blood flow/2.7 mL/min)**
Routine treatments
80 mL/min
Target volume:
Patient's 1.6-fold blood volume
Depends on the patient's clinical
situation and on the prescription of the
treating physician. It is recommended
to use the smallest DALI Kit
configuration possible required to
achieve the treatment goals. In
consideration of the extracorporeal
volume, we do not recommend the
DALI 1250 configuration for patients
weighing less than 50 kg.
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