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

JRCT ID: jRCT1051240161

Registered date:15/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lumbar spinal canal stenosis, lumbar disc herniation, cervical spondylotic myelopathy
• Date of first enrollment: 15/10/2024
• Target sample size: 160
• Study type: Interventional
• Intervention(s): Patients who meet the inclusion criteria and are enrolled will be randomly assigned to the aspirin continuation or discontinuation group.

Outcome(s)

• Primary Outcome: Total intraoperative and postoperative blood loss

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Tamai Koji