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Recruiting slower than expected.
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The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with pertrochanteric hip fractures.
Tranexamic acid is a well known drug used in many types of surgery. The investigators wish to investigate if the use of tranexamic acid can reduce the peri- and post-operative blood loss in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric hip fracture.
An interim analysis was planned when reaching 60 inclusions. The interim analysis was conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was considered a reason to halt the study. The 0.001 level was chosen as a simple approach to this interim analysis from the Haybittle-Peto boundary
Studies have shown that hip fractures have a hidden blood loss besides the recorded perioperative blood loss. Patients who are osteosynthesised with an intramedullary nail have been shown to have the largest hidden blood loss.
Postoperative anaemia is associated with a higher morbidity and mortality. We wish to investigate the possibility of reducing this hidden blood loss, with the use of a well known drug (tranexamic acid) that is widely used to reduce blood loss in other forms of surgery and in multitraumatized patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients are given saline instead of tranexamic acid in the placebo group |
|
| Tranexamic Acid | Active Comparator | Tranexamic acid; 1 gram as a bolus prior to surgery. 3 grams of Tranexamic acid in 1 liter of saline as a 24 hour infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 1 g of tranexamic acid as a bolus immediately before surgery 3 g of tranexamic acid in 24hours postop. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Blood Loss | Calculated as described by Foss et al in their study of 2006. "Hidden Blood Loss After Surgery for Hip Fracture" JBJS br. 2006. | time in hospital (approximately 10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusions | Information from local blood bank | From admission to third day after surgery. |
| Mortality | Mortality is obtained via central personal registration system (Danish CPR system) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter T Tengberg, MD | Hvidovre University Hospital | Principal Investigator |
| Henrik Palm, MD | Hvidovre University Hospital | Study Chair |
| Anders Troelsen, PhD | Hvidovre University Hospital | Study Director |
| Michael Krasheninnikoff, MD | Hvidovre University Hospital | Study Chair |
| Nicolai B Foss, PhD, Dr.Med | Hvidovre University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre Hospital | Hvidovre | Copenhagen | 2650 | Denmark |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D000740 | Anemia |
| D019106 | Postoperative Hemorrhage |
| 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 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Identical syringe and drip used as in the intervention, to ensure blinding. |
|
|
| 30 days and 90 days follow up |
| Thromboembolic Event (clinical, NOT by routine ultrasound measurement) | Obtained in-hospital, through routine check ups daily. After discharge; obtained from patient records. | 90 days follow up |
| D007869 |
| Leg Injuries |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |