Prevention of Postoperative Bleeding in Subcapital Femoral Fractures

Phase 3 Completed 161 enrolled Sant Pau Research Institute

RandomizedParallel-groupOpen-labelTreatment

Summary

The main hypothesis of this clinical trial is that the use of intra-articular tranexamic acid and the fibrin glue plus usual hemostasis will reduce at least a 25% the postoperative blood loss with respect to usual hemostasis in patients undergoing subcapital femoral fractures.

Timeline

Start: 2013-02
Primary completion: 2015-04
Completion: 2016-03

Publications

Results Martínez-Zapata MJ, Jordán M, Aguilera X, Cánovas E, Urrutia G (en nombre del grupo TRANEXFER). Estudio prospectivo multicéntrico de una cohorte para evaluar la calidad de vida de pacientes intervenidos de fractura subcapital de fémur. Trauma 2014; 25 (4): 188-195.
Merchan-Galvis A, Posso M, Canovas E, Jordan M, Aguilera X, Martinez-Zapata MJ. Quality of life and cost-effectiveness analysis of topical tranexamic acid and fibrin glue in femur fracture surgery. BMC Musculoskelet Disord. 2022 Aug 31;23(1):827. doi: 10.1186/s12891-022-05775-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fibrinogen Concentrate Human	Protein / enzyme biologic	5 ml	Other
Subject	Tranexamic Acid	Small molecule	1 g	Other

Indications

No indication recorded.