Clinical trial NCT02150720: Prevention of Postoperative Bleeding in Subcapital Femoral Fractures
Official title: Prevention of Postoperative Bleeding in Femoral Fractures: a Multicenter, Randomized, Controlled, Parallel Clinical Trial to Assess the Efficacy of Tranexamic Acid and Fibrin Glue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Fracture
Blood Loss
Keywords: Hip fractures
Clinical Trial
Randomized
Fibrin glue
Tranexamic acid
Blood loss
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Patients with unilateral subcapital femoral fracture
* Patients requiring hip replacement (total or partial)
* Signed informed consent from the patient or legal representative

Exclusion Criteria:

* Known allergy to fibrin glue and tranexamic acid
* Multiple fractures
* Pathological fractures
* Contraceptives or estrogen therapy
* Use of blood salvage during surgery
* History compatible with thromboembolic disease:

  * Cerebral vascular accident
  * Ischemic heart disease (myocardial infarction, angina )
  * Deep vein thrombosis
  * Pulmonary Embolism
  * Peripheral arterial vasculopathy
  * Patients with thrombogenic arrhythmias
  * Patients with cardiovascular stents
  * Prothrombotic alterations in coagulation

Primary outcomes:
measure: Blood loss (ml) after surgery
timeFrame: The first postoperative 24h
Secondary outcomes:
measure: Hidden blood loss
timeFrame: The first postoperative five days
measure: Proportion of patients requiring blood transfusion
timeFrame: The first postoperative ten days
measure: Units of blood transfused
timeFrame: The first postoperative ten days
measure: Proportion of patients with wound infection
timeFrame: The first postoperative month
measure: Proportion of patients with wound dehiscence
timeFrame: The first postoperative month
measure: Deep venous thrombosis
timeFrame: The first postoperative ten days
measure: Length of hospital stay
timeFrame: The first postoperative ten days
measure: Quality of life measured with the generic EQ-5D -5L
timeFrame: Preoperatively, at 5 days postoperatively , 1-2, 6 and 12 months postoperative follow-up
measure: Mortality
timeFrame: During the 12 month of follow-up after surgery
measure: Direct cost
timeFrame: During the first postoperative month
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol de Badalona
state: Barcelona
city: Sabadell
country: Spain
facility: Parc Taulí
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua Terrassa
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Terrassa-Consorci Sanitari de Terrassa
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Iberoamerican Cochrane Centre. Research Institut Hospital de la Santa Creu i Sant Pau. IIB Sant Pau
name: MJ Martínez-Zapata, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.