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

NCT01535781 | Terminated DMC

• 1 other identifier: TA0001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Hip Fracture; Anemia

Keywords

pertrochanteric fracture; tranexamic acid; postoperative blood loss; blood loss; hidden blood loss; blood transfusions

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Transfusions

  From admission to third day after surgery.

• Mortality

  30 days and 90 days follow up

• Thromboembolic Event (clinical, NOT by routine ultrasound measurement)

  90 days follow up

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Tranexamic Acid

ACTIVE COMPARATOR

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

Interventions

Tranexamic Acid DRUG

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

Also known as: Cyklokapron (tranexamic acid)

Tranexamic Acid

Placebo DRUG

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

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planned to undergo osteosynthesis with short intramedullary nail for a pertrochanteric hip fracture.
• ASA score 3, 2 or 1

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

MeSH Terms

Conditions

Hip Fractures; Anemia; Postoperative Hemorrhage; Hemorrhage

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Peter T Tengberg, MD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Henrik Palm, MD

  Hvidovre University Hospital

  STUDY CHAIR

• Anders Troelsen, PhD

  Hvidovre University Hospital

  STUDY DIRECTOR

• Michael Krasheninnikoff, MD

  Hvidovre University Hospital

  STUDY CHAIR

• Nicolai B Foss, PhD, Dr.Med

  Hvidovre University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: February 20, 2012
• Study Start: September 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 5, 2015

Record last verified: 2015-02

Locations

DK (1)