Evaluation of Topical and Intravenous Tranexamic Acid in Surgical Treatment of Lumbar Degenerative Disease

• Status: Enrolling by invitation
• Trial end date: 0000-00-00
• Target enrollment: 144
• Participant gender: Both

Summary

Lumbar degenerative disease surgery entails in a high blood loss, requiring often for blood transfusion. The cost and risks involved in the use of allogeneic blood have motivated research methods to reduce operative bleeding in these patients. One such method is the use of anti-fibrinolytic drugs, among which is tranexamic acid.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Traumatologia e Ortopedia
• Treatments: Pharmaceutical Solutions; Tranexamic Acid
• Last Updated: 2016-05-09

Criteria

Inclusion Criteria:

• Diagnosis of lumbar degenerative disease with segmental instability and/or lumbar stenosis;

• Having a body weight less than 100kg

• Indicative of Posterior lumbar interbody fusion in three levels or less

Exclusion Criteria:

• Diagnosis of renal and hepatic insufficiency

• History of bleeding disorders and thromboembolism

• History coronary heart disease

• History peripheral vascular disease

• Commonly used anticoagulant drug

• Contraindication to the use of tranexamic acid

• Surgery history in the spine

• Religious restrictions on blood transfusion