Clinical trial NCT01535781: Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?
Official title: Effect of Tranexamic Acid on Blood Loss and Transfusion Need in Patients Operated With a Short Intramedullary Nail, for Pertrochanteric Fractures .
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Fracture
Anemia
Keywords: pertrochanteric fracture
tranexamic acid
postoperative blood loss
blood loss
hidden blood loss
blood transfusions
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Blood Loss
timeFrame: time in hospital (approximately 10 days)
Secondary outcomes:
measure: Transfusions
timeFrame: From admission to third day after surgery.
measure: Mortality
timeFrame: 30 days and 90 days follow up
measure: Thromboembolic Event (clinical, NOT by routine ultrasound measurement)
timeFrame: 90 days follow up
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
state: Copenhagen
Study officials:
affiliation: Hvidovre University Hospital
name: Peter T Tengberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Henrik Palm, MD
role: STUDY_CHAIR
affiliation: Hvidovre University Hospital
name: Anders Troelsen, PhD
role: STUDY_DIRECTOR
affiliation: Hvidovre University Hospital
name: Michael Krasheninnikoff, MD
role: STUDY_CHAIR
affiliation: Hvidovre University Hospital
name: Nicolai B Foss, PhD, Dr.Med
role: STUDY_CHAIR
References: