NCT02428868

Brief Summary

It is a prospective randomized controlled study aiming to test if tranexamic acid combined to intravenous iron before and after surgery for hip fracture in elderly can decrease peri-operative red cell transfusion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

April 14, 2015

Last Update Submit

April 28, 2015

Conditions

Hip FractureAnemia

Keywords

hip fractureanemiablood transfusiontranexamic acidintravenous iron

Outcome Measures

Primary Outcomes (1)

  • transfusion

    percentage of patients who receive red-cell transfusion during hospitalization

    5 days

Secondary Outcomes (14)

  • Average red-cell packs per patient

    5 days

  • blood loss

    5 days

  • haemoglobin level

    day 1

  • haemoglobin level

    day 2

  • haemoglobin level

    day 5

  • +9 more secondary outcomes

Study Arms (3)

Tranexamic acid - intravenous iron

EXPERIMENTAL

IV iron (Ferroven®) : 2 vials of 10 mL containing each one 100 mg iron, diluted in 100 mL normal saline over 30 minutes before induction of anesthesia and repeated on day two and three. IV Tranexamic acid (Exacyl®): 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later.

Drug: tranexamic acid (Exacyl®)Drug: intravenous iron (Ferroven®)

Tranexamic acid

ACTIVE COMPARATOR

IV Tranexamic acid (Exacyl®): 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later.

Drug: tranexamic acid (Exacyl®)

Placebo

PLACEBO COMPARATOR

20 mL saline, in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.

Other: Saline

Interventions

tranexamic acid (Exacyl®)DRUG

1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later

Tranexamic acidTranexamic acid - intravenous iron
intravenous iron (Ferroven®)DRUG

2 vials of 10 mL containing each one 100 mg iron, diluted in 100 mL normal saline over 30 minutes before induction of anesthesia and repeated on day two and three.

Tranexamic acid - intravenous iron
SalineOTHER

20 mL saline in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing hip fracture surgery within 72 h after trauma.

You may not qualify if:

  • Vascular events within the last 2 months such as cerebrovascular accident (CVA), Myocardial infarction (MI), Venous Thromboembolism (VTE) and/or recurrent VTE or arterial thrombosis.
  • Patients receiving anticoagulation therapy with warfarin or clopidogrel.
  • History of seizures.
  • Multiple fractures.
  • Transfusion received during admission, prior to surgery (Hb\< 8g/dl).
  • Creatinine clearance less than 30 mL/min
  • Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
  • Coronary stent placement within the previous 6 months
  • Disseminated intravascular coagulation
  • Subarachnoid hemorrhage
  • Allergy for tranexamic acid
  • Hypersensitivity to Iron sucrose or any component of the formulation
  • Clinical signs of acute thromboembolic event
  • Malignancy
  • Body weight \> 100kg
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Mohamed Kassab d'Orthopédie

Manouba, La Manouba, Tunisia

Location

Related Publications (5)

  • Hagino T, Ochiai S, Sato E, Maekawa S, Wako M, Haro H. The relationship between anemia at admission and outcome in patients older than 60 years with hip fracture. J Orthop Traumatol. 2009 Sep;10(3):119-22. doi: 10.1007/s10195-009-0060-8. Epub 2009 Aug 26.

    PMID: 19707842BACKGROUND

  • Carson JL, Terrin ML, Noveck H, Sanders DW, Chaitman BR, Rhoads GG, Nemo G, Dragert K, Beaupre L, Hildebrand K, Macaulay W, Lewis C, Cook DR, Dobbin G, Zakriya KJ, Apple FS, Horney RA, Magaziner J; FOCUS Investigators. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med. 2011 Dec 29;365(26):2453-62. doi: 10.1056/NEJMoa1012452. Epub 2011 Dec 14.

    PMID: 22168590BACKGROUND

  • Spahn DR. Anemia and patient blood management in hip and knee surgery: a systematic review of the literature. Anesthesiology. 2010 Aug;113(2):482-95. doi: 10.1097/ALN.0b013e3181e08e97.

    PMID: 20613475RESULT

  • Serrano-Trenas JA, Ugalde PF, Cabello LM, Chofles LC, Lazaro PS, Benitez PC. Role of perioperative intravenous iron therapy in elderly hip fracture patients: a single-center randomized controlled trial. Transfusion. 2011 Jan;51(1):97-104. doi: 10.1111/j.1537-2995.2010.02769.x.

    PMID: 20630042RESULT

  • Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314.

    PMID: 19926634RESULT

MeSH Terms

Conditions

Hip FracturesAnemia

Interventions

Tranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Olfa Kaabachi, Professor

    Institut Mohamed Kassab d'Orthopédie

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olfa Kaabachi, Professor

CONTACT

+21698317381olfa.kaabachi@gnet.tn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 29, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations

TU(1)