To measure DOAC levels just before surgery of all DOAC patients in the LUMC with elective surgery for which ceasing of DOAC treatment is required.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
DOAC levels measured by liquid chromatography-mass spectrometry (LC-MS) will be
the main outcome of the study.
Secondary outcome
- DOAC levels measured by specific coagulation tests for DOACs (diluted
thrombin time or anti-Xa levels depending on the DOAC used)
- Prothrombin time (PT)
- Activated Partial Thromboplastin Time (APTT)
- Perioperative blood loss
- Blood product received during surgery and other major bleeding during up to
30 days after surgery
Background summary
Each year more than 400 000 people receive an oral anticoagulant drug in the
Netherlands (i.e. 2.5% of the population) for the acute treatment and long-term
prevention of thromboembolism in venous thrombosis and non-valvular atrial
fibrillation, respectively [1]. Currently, the majority of these patients use
vitamin K antagonists (VKAs), but the proportion of direct oral anticoagulant
(DOAC) users is steadily rising [2]. The advantage of DOACs (i.e. dabigatran,
rivaroxaban and apixaban) over VKAs is their fixed dose, which obviates the
need for routine laboratory monitoring and monitoring prior to surgery.
Nevertheless, the current protocol on emergency procedures in DOAC users states
that surgical procedures can be only be performed safely when apixaban- or
rivaroxaban levels are below 30 ng/ml or when dabigatran levels are below 50
ng/ml [3]. These DOAC levels have been determined pragmatically. The protocol
on elective surgery states that DOAC users should discontinue treatment a fixed
period before surgery, which is based on the average half-life of the DOACs and
the patient*s kidney function. Nevertheless, it is not known how well the
average half-life of DOACs in the population is applicable to the individual
patient and how well patients adhere to the stopping protocol. Both could
result in high DOAC levels before surgery with concurrent risk of excess
bleeding. Indeed, a recent study [4] showed that with the current protocol, 15%
of dabigatran users had elevated levels (above 50 ng/ml) just before surgery.
It is not known to what extent levels of other DOACs are unacceptably high
before elective surgery and whether these high levels lead to increased blood
loss during the surgical procedure.
Study objective
To measure DOAC levels just before surgery of all DOAC patients in the LUMC
with elective surgery for which ceasing of DOAC treatment is required.
Study design
Observational cohort study
Study burden and risks
Patients will give 40 ml of blood for the research. Another burden can be that
a venapuncture may be necessary in case that blood drawl is not possible via
the line that is already present for the surgery
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
1. Aged 18 years or above.
2. Use of a DOAC that was initiated at least one week before surgery (apixaban,
rivaroxaban or dabigatran).
3. Have an elective surgery in the LUMC or Haga Teaching Hospital for which
discontinuation of DOAC treatment is required.
Exclusion criteria
1. Be intellectually disabled.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-001443-31-NL |
| CCMO | NL65677.058.18 |