Hip Fracture, Blood Loss
Conditions
Keywords
Hip fractures, Clinical Trial, Randomized, Fibrin glue, Tranexamic acid, Blood loss
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.
Interventions
DRUGTranexamic Acid
1g intra-articular before closing the wound surgery
DRUGFibrin glue
5mL intra-articular before closing the wound surgery
PROCEDUREElectrocauterization
Coagulation blood from vessels by means of a electrocautery.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss (ml) after surgery | The first postoperative 24h | The blood lost from the wound will be collected by a drainage system during the first 24 hours postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with wound infection | The first postoperative month | — |
| Proportion of patients with wound dehiscence | The first postoperative month | — |
| Deep venous thrombosis | The first postoperative ten days | — |
| Hidden blood loss | The first postoperative five days | The hidden blood loss is the total blood loss calculated by the formula of Nadler minus the blood loss by drain. |
| Units of blood transfused | The first postoperative ten days | — |
| Length of hospital stay | The first postoperative ten days | Time from hip surgery until hospital discharge |
| Quality of life measured with the generic EQ-5D -5L | Preoperatively, at 5 days postoperatively , 1-2, 6 and 12 months postoperative follow-up | — |
| Mortality | During the 12 month of follow-up after surgery | — |
| Direct cost | During the first postoperative month | — |
| Proportion of patients requiring blood transfusion | The first postoperative ten days | — |
Countries
Spain
Outcome results
None listed