drugset / Trial / NCT02153593

Postoperative Bleeding Prevention in Massive Bone Tumour Resection

NCT02153593

Phase 3 Terminated 56 enrolled Sant Pau Research Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

Massive bone tumour resection is often associated with important postoperative bleeding. This may determine systemic (anaemia), as well as local complications (wound healing, seroma, haematoma). The objective of this study is to determine whether the use of topical tranexamic acid or topical Evicel® will reduce the perioperative bleeding comparing it with usual haemostasis.

Timeline

Start
2013-03
Primary completion
2015-03
Completion
2015-05

Publications

  • Background Ibáñez AP, Martinez-Zapata MJ, Tarragó LT, Balaguer MB, Roig XA, Joy IG, Areizaga L, Merino J, Alcalá R, Tranextum Study Group. Postoperative bleeding prevention in massive bone tumour resection: a multicentric, randomized, parallel, controlled trial to assess the efficacy of tranexamic acid versus Evicel and usual haemostasis [protocol]. Basic and Clinical Pharmacology. 2014; 115 (Suppl 3): 20-21.

Drugs

EvaluationDrugModalityDoseRoute
Subject Fibrinogen Concentrate Human Protein / enzyme biologic 5 ml Other
Subject Tranexamic Acid Small molecule 1 g Other

Indications