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| ID | Type | Description | Link |
|---|---|---|---|
| EC11-341 | Other Grant/Funding Number | Ministry of Health and Social Policy 2011 | |
| 2011-006278-15 | EudraCT Number | ||
| SA/12/AYU/456 | Other Grant/Funding Number | Fundación MAPFRE 2012 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Experimental | Tranexamic acid, 1g intra-articular before closing the surgery wound |
|
| Fibrin glue | Experimental | One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery, |
|
| Usual hemostasia | Active Comparator | Electrocauterization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 1g intra-articular before closing the wound surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss (ml) after surgery | The blood lost from the wound will be collected by a drainage system during the first 24 hours postoperatively. | The first postoperative 24h |
| Measure | Description | Time Frame |
|---|---|---|
| Hidden blood loss | The hidden blood loss is the total blood loss calculated by the formula of Nadler minus the blood loss by drain. | The first postoperative five days |
| Proportion of patients requiring blood transfusion |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| MJ Martínez-Zapata, MD, PhD | Iberoamerican Cochrane Centre. Research Institut Hospital de la Santa Creu i Sant Pau. IIB Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol de Badalona | Badalona | Barcelona | 08916 | Spain | ||
| Hospital de la Santa Creu i Sant Pau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 36045358 | Derived | 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. |
| Label | URL |
|---|---|
| Publication of quality of life (subgroup of patients) | View source |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D015718 | Fibrin Tissue Adhesive |
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Fibrin glue | Drug | 5mL intra-articular before closing the wound surgery |
|
|
| Electrocauterization | Procedure | Coagulation blood from vessels by means of a electrocautery. |
|
| The first postoperative ten days |
| Units of blood transfused | The first postoperative ten days |
| 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 |
| Length of hospital stay | Time from hip surgery until hospital discharge | The first postoperative ten days |
| 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 |
| Barcelona |
| Barcelona |
| 08025 |
| Spain |
| Hospital Clinic | Barcelona | Barcelona | 08036 | Spain |
| Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| Hospital Universitari Mútua Terrassa | Terrassa | Barcelona | 08221 | Spain |
| Hospital Universitari Terrassa-Consorci Sanitari de Terrassa | Terrassa | Barcelona | 08227 | Spain |
| D007869 |
| Leg Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005337 |
| Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |