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

NCT01535781 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2015-02-05

No results posted yet for this study

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

Conditions

Interventions

DRUG

Tranexamic Acid

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Peter T Tengberg, MD · Hvidovre University Hospital

  • Henrik Palm, MD · Hvidovre University Hospital

  • Anders Troelsen, PhD · Hvidovre University Hospital

  • Michael Krasheninnikoff, MD · Hvidovre University Hospital

  • Nicolai B Foss, PhD, Dr.Med · Hvidovre University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-06-30
Completion
2014-08-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01535781 on ClinicalTrials.gov