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

Effect of Tranexamic Acid on Blood Loss and Transfusion Need in Patients Operated With a Short Intramedullary Nail, for Pertrochanteric Fractures .

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01535781

Enrollment

Registered

2012-02-20

Start date

2011-09-30

Completion date

2014-08-31

Last updated

2015-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Hip Fracture

Keywords

pertrochanteric fracture, tranexamic acid, postoperative blood loss, blood loss, hidden blood loss, blood transfusions

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.

Interventions

DRUGTranexamic Acid

1 g of tranexamic acid as a bolus immediately before surgery 3 g of tranexamic acid in 24hours postop.

DRUGPlacebo

Identical syringe and drip used as in the intervention, to ensure blinding.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Total Blood Loss	time in hospital (approximately 10 days)	Calculated as described by Foss et al in their study of 2006. Hidden Blood Loss After Surgery for Hip Fracture JBJS br. 2006.

Secondary

Measure	Time frame	Description
Transfusions	From admission to third day after surgery.	Information from local blood bank
Mortality	30 days and 90 days follow up	Mortality is obtained via central personal registration system (Danish CPR system)
Thromboembolic Event (clinical, NOT by routine ultrasound measurement)	90 days follow up	Obtained in-hospital, through routine check ups daily. After discharge; obtained from patient records.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026