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

This study has been terminated.
(Recruiting slower than expected.)
Sponsor:
Information provided by (Responsible Party):
Peter Toft Tengberg, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01535781
First received: November 23, 2011
Last updated: February 3, 2015
Last verified: February 2015
  Purpose

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


Condition Intervention
Hip Fracture
Anemia
Drug: Tranexamic Acid
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Tranexamic Acid on Blood Loss and Transfusion Need in Patients Operated With a Short Intramedullary Nail, for Pertrochanteric Fractures .

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Total Blood Loss [ Time Frame: time in hospital (approximately 10 days) ] [ Designated as safety issue: Yes ]
    Calculated as described by Foss et al in their study of 2006. "Hidden Blood Loss After Surgery for Hip Fracture" JBJS br. 2006.


Secondary Outcome Measures:
  • Transfusions [ Time Frame: From admission to third day after surgery. ] [ Designated as safety issue: No ]
    Information from local blood bank

  • Mortality [ Time Frame: 30 days and 90 days follow up ] [ Designated as safety issue: No ]
    Mortality is obtained via central personal registration system (Danish CPR system)

  • Thromboembolic Event (clinical, NOT by routine ultrasound measurement) [ Time Frame: 90 days follow up ] [ Designated as safety issue: Yes ]
    Obtained in-hospital, through routine check ups daily. After discharge; obtained from patient records.


Enrollment: 72
Study Start Date: September 2011
Study Completion Date: August 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Patients are given saline instead of tranexamic acid in the placebo group
Drug: Placebo
Identical syringe and drip used as in the intervention, to ensure blinding.
Other Name: Saline
Active Comparator: Tranexamic Acid
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.
Drug: Tranexamic Acid
1 g of tranexamic acid as a bolus immediately before surgery 3 g of tranexamic acid in 24hours postop.
Other Name: Cyklokapron (tranexamic acid)

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535781

Locations
Denmark
Hvidovre Hospital
Hvidovre, Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Peter T Tengberg, MD Hvidovre University Hospital
Study Chair: Henrik Palm, MD Hvidovre University Hospital
Study Director: Anders Troelsen, PhD Hvidovre University Hospital
Study Chair: Michael Krasheninnikoff, MD Hvidovre University Hospital
Study Chair: Nicolai B Foss, PhD, Dr.Med Hvidovre University Hospital
  More Information

Responsible Party: Peter Toft Tengberg, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01535781     History of Changes
Other Study ID Numbers: TA0001 
Study First Received: November 23, 2011
Last Updated: February 3, 2015
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
pertrochanteric fracture
tranexamic acid
postoperative blood loss
blood loss
hidden blood loss
blood transfusions

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Hemorrhage
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on August 23, 2016