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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01535781
• Other study ID #: TA0001
• Status: Terminated
• Phase: N/A
• First received: November 23, 2011
• Last updated: February 3, 2015
• Start date: September 2011
• Est. completion date: August 2014

Study information

• Verified date: February 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Fractures, Bone
• Hemorrhage
• Hip Fracture
• Hip Fractures

Intervention

Drug:
• Tranexamic Acid
1 g of tranexamic acid as a bolus immediately before surgery 3 g of tranexamic acid in 24hours postop.
• Placebo
Identical syringe and drip used as in the intervention, to ensure blinding.

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Transfusions	Information from local blood bank	From admission to third day after surgery.	No
Secondary	Mortality	Mortality is obtained via central personal registration system (Danish CPR system)	30 days and 90 days follow up	No
Secondary	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	Yes