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

NCT ID: NCT01535781

Last Updated: 2015-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-08-31

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.

Conditions

Hip Fracture; Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

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

Interventions

Tranexamic Acid

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Cyklokapron (tranexamic acid); Saline

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter Toft Tengberg

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter T Tengberg, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Henrik Palm, MD

Role: STUDY_CHAIR

Hvidovre University Hospital

Anders Troelsen, PhD

Role: STUDY_DIRECTOR

Hvidovre University Hospital

Michael Krasheninnikoff, MD

Role: STUDY_CHAIR

Hvidovre University Hospital

Nicolai B Foss, PhD, Dr.Med

Role: STUDY_CHAIR

Hvidovre University Hospital

Locations

Hvidovre Hospital

Hvidovre, Copenhagen, Denmark

Countries

Denmark

Other Identifiers

TA0001

Identifier Type: -

Identifier Source: org_study_id