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
Bron
Verkorte titel
Aandoening
Post-operative hemorrhagic complications and thrombo-embolic complications after neurosurgical spinal surgeries in patients using aspirin anti-thrombotic medication.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primay outcome measures include perioperative blood loss, hemorrhage related complications and need for reoperation.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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).
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8986 |
| Ander register | METC Leiden Den Haag Delft : P14.296 METC LDD |
| CCMO | NL71200.058.20 |
| OMON | NL-OMON54741 |