Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?

Hvidovre University Hospital

Status: Terminated

Conditions: Anemia; Hip Fracture

Treatments: Drug: Placebo; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01535781

TA0001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients planned to undergo osteosynthesis with short intramedullary nail for a pertrochanteric hip fracture.
• ASA score 3, 2 or 1

Exclusion criteria

• Allergy for tranexamic acid
• Clinical signs of acute thromboembolic event
• Renal function impairment (S-creatinin>120micromol/l)
• Active thrombotic disease or DIC
• K-vitamin antagonist treatment
• Malignancy
• Pathological fracture
• Previously operated in same hip
• BW > 100kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients are given saline instead of tranexamic acid in the placebo group

Treatment:

Drug: Placebo

Tranexamic Acid

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid