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Comparative trial to examine the perioperative safety of spinal surgery under low-dose aspirin continuation

A multicenter, randomized, comparative trial evaluating the safeness of perioperative period of spinal surgery under low-dose aspirin continuation - ASPINE study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1051240161
Enrollment
160
Registered
2024-10-15
Start date
2024-10-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar spinal canal stenosis, lumbar disc herniation, cervical spondylotic myelopathy

Interventions

Patients who meet the inclusion criteria and are enrolled will be randomly assigned to the aspirin continuation or discontinuation group.

Sponsors

Tamai Koji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. patients scheduled for spine surgery (cervical posterior decompression, cervical posterior decompression and fusion, cervical anterior decompression and fusion, lumbar posterior decompression and fusion, lumbar posterior decompression and fusion, lumbar posterolateral fusion) taking aspirin who visited the Osaka Public University Hospital Department of Orthopaedic Surgery and related facilities during the period from the time of jRCT publication to March 2026. 2. Cases where the name of the disease for which the patient was prescribed aspirin could be confirmed, and where it was possible to discontinue the medication before surgery. 3. if the procedure is a fusion surgery, cases of fusion surgery within 2 vertebral levels. 4. patients who are 40 years of age or older at the time of consent 5. patients who are able to make outpatient visits in accordance with the study schedule

Exclusion criteria

Exclusion criteria: 1.Patients taking antiplatelet agents other than aspirin 2.Patients taking multiple antiplatelet agents 3.Patients taking anticoagulants 4. patients with more than three fixed vertebrae 5.Patients with known bleeding disorder 6.Patients undergoing revision surgery 7. cases with tumor, trauma, or infection 8. patients with severe liver disease (AST (GOT) or ALT (GPT) > 100 U) 9. patients with a history of serious drug allergy or serious adverse drug reactions 10. other patients who are judged to be unsuitable as subjects by the investigators.

Design outcomes

Primary

MeasureTime frame
Total intraoperative and postoperative blood loss

Secondary

MeasureTime frame
1. operative time, length of hospital stay 2. incidence of hematoma requiring reoperation, dural injury rate, blood transfusion rate, thrombosis rate, and readmission rate within 30 days after discharge 3. preoperative, 3-month postoperative investigator-reported outcome (JOA score), Patient-Reported Outcome (common: VAS score, EQ5D, surgical satisfaction, cervical spine: JOACMEQ, NDI, lumbar spine: JOABPEQ, ODI)

Contacts

Public ContactKoji Tamai

Osaka Metropolitan University Hospital

koji.tamai.707@gmail.com+81-666453851

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026