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

Primary Purpose

Hip Fracture, Anemia

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring pertrochanteric fracture, tranexamic acid, postoperative blood loss, blood loss, hidden blood loss, blood transfusions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hvidovre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Tranexamic Acid

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Transfusions
Information from local blood bank
Mortality
Mortality is obtained via central personal registration system (Danish CPR system)
Thromboembolic Event (clinical, NOT by routine ultrasound measurement)
Obtained in-hospital, through routine check ups daily. After discharge; obtained from patient records.

Full Information

First Posted
November 23, 2011
Last Updated
February 3, 2015
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01535781
Brief Title
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

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Recruiting slower than expected.
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Anemia
Keywords
pertrochanteric fracture, tranexamic acid, postoperative blood loss, blood loss, hidden blood loss, blood transfusions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients are given saline instead of tranexamic acid in the placebo group
Arm Title
Tranexamic Acid
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Cyklokapron (tranexamic acid)
Intervention Description
1 g of tranexamic acid as a bolus immediately before surgery 3 g of tranexamic acid in 24hours postop.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Identical syringe and drip used as in the intervention, to ensure blinding.
Primary Outcome Measure Information:
Title
Total Blood Loss
Description
Calculated as described by Foss et al in their study of 2006. "Hidden Blood Loss After Surgery for Hip Fracture" JBJS br. 2006.
Time Frame
time in hospital (approximately 10 days)
Secondary Outcome Measure Information:
Title
Transfusions
Description
Information from local blood bank
Time Frame
From admission to third day after surgery.
Title
Mortality
Description
Mortality is obtained via central personal registration system (Danish CPR system)
Time Frame
30 days and 90 days follow up
Title
Thromboembolic Event (clinical, NOT by routine ultrasound measurement)
Description
Obtained in-hospital, through routine check ups daily. After discharge; obtained from patient records.
Time Frame
90 days follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter T Tengberg, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henrik Palm, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anders Troelsen, PhD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Krasheninnikoff, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nicolai B Foss, PhD, Dr.Med
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hvidovre Hospital
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

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

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