The aim of this study is to investigate the non-inferiority of perioperative continuation of aspirin patients undergoing spinal surgery, compared with the current policy of perioperative discontinuation of aspirin.
ID
Source
Brief title
Health condition
Post-operative hemorrhagic complications and thrombo-embolic complications after neurosurgical spinal surgeries in patients using aspirin anti-thrombotic medication.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primay outcome measures include perioperative blood loss, hemorrhage related complications and need for reoperation.
Secondary outcome
Secondary outcome is the reduction of cardiac and neurologic thrombotic perioperative events within 30 days after surgery.
Background summary
Aspirin is typically discontinued in cranial and spinal surgery because of increased risk of hemorrhagic complications, but comes together with the risk of resulting in an increase of cardiac and neurologic thrombotic perioperative events.
Study objective
The aim of this study is to investigate the non-inferiority of perioperative continuation of aspirin patients undergoing spinal surgery, compared with the current policy of perioperative discontinuation of aspirin.
Study design
Pre-operative assessment: informed consent, inclusion and randomisation. Direct post-operative assessment: operative blood loss (suction system and gauzes), first day blood loss in subcutaneous drain, level of mobilisation, days of clinical admission, level of pain. Outpatient clinic check up: woundinspection (infection, wound recovery), thrombo-embolic complications (neuro-vascular/cardiologic).
Intervention
Current practice guidelines recommend the discontinuation of aspirin 5 days pre-operatively until at least 3 days post-operatively. The intervention in the Aspin-study is to observe the rate of hemorhaghic complictions in patients undergoing spinal neurosurgery that continue the intake of aspirin peri-operatively, which is the intervention group.
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Scheduled spinal surgery • Preoperative use of aspirin • Age >18
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study: • Surgery with high risk for hemorrhage such as tumors requiring preoperative embolization • Staged surgeries lasting more than one day • Patients with a pre-existing coagulopathy • Patients using antithrombotic drugs or other platelet aggregation inhibitors than aspirin • Patients with absolute contraindication for discontinuing aspirin (e.g. coronary stenting within 1 year) • Patients aged under 18 • Emergency surgical procedures
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8986 |
| Other | METC Leiden Den Haag Delft : P14.296 METC LDD |
| CCMO | NL71200.058.20 |
| OMON | NL-OMON54741 |