NCT00881088

Brief Summary

Objective: The purpose of this study is to determine the need for thromboprophylaxis in patients with a fracture of the lower extremity being treated conservatively in a below-knee plaster cast and to assess if both of the two tested prophylactic treatments are effective for this indication. Hypothesis: Nadroparine and Fondaparinux are both effective in preventing a thromboembolic event in patients with a nonsurgical fracture of a lower extremity immobilised in a below-knee plaster cast.

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
669

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2009

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

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, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

December 18, 2012

Status Verified

May 1, 2009

Enrollment Period

4 years

First QC Date

April 13, 2009

Last Update Submit

December 15, 2012

Conditions

Deep Vein ThrombosisPulmonary Embolism

Keywords

Deep vein trombosisProfylaxisBelow knee plaster castAnkle fracture

Outcome Measures

Primary Outcomes (1)

  • Primary outcome measure is deep vein trombosis as detected by venous duplex

    subjects are assessed after 6 weeks

Secondary Outcomes (1)

  • Bleeding complications

    6 weeks

Study Arms (3)

1

NO INTERVENTION

Patients randomized to the no intervention group

Nadroparin

EXPERIMENTAL

Subjects randomized to group receiving nadroparin 0,3 cc daily during immobilization

Drug: Nadroparin

Fondaparinux

EXPERIMENTAL

Subjects randomized to fondaparinux 2,5 mg daily group during immobilization

Drug: Fondaparinux

Interventions

NadroparinDRUG

nadroparin 0,3 cc once daily during immobilization period

Also known as: Fraxiparin
Nadroparin
FondaparinuxDRUG

Fondaparinux 2,5 mg daily during immobilization period

Also known as: Arixtra
Fondaparinux

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years
  • with a nonsurgical fracture of the lower extremity requiring immobilisation in a below-knee plaster cast for a minimum of 4 weeks.

You may not qualify if:

  • Delay between injury and Emergency Department visit greater than three days
  • Pregnancy/ lactation
  • Body weight \< 50 kg
  • Severe hepatic impairment
  • Severe renal impairment (creatinin-clearance \< 30 ml/min)
  • Known hypersensitivity to nadroparine or fondaparinux
  • Pre-existing venous thromboembolism
  • Pre-existing post-thrombotic syndrome
  • Documented congenital or acquired bleeding tendency/disorder(s)
  • Active, clinically significant bleeding
  • Clinically significant bleeding within the past six months
  • Previous or active bleeding from the digestive tract by peptic ulcer, tumours, hiatus hernia or diverticulosis
  • Severe hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg)
  • Bacterial endocarditis
  • Haemorrhagic stroke within the previous two months
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Medical Center Nijmegen

Nijmegen, Gelderland, Netherlands

RECRUITING

Medical Center Alkmaar

Alkmaar, North Holland, 1815 JD, Netherlands

RECRUITING

VU University Medical Center

Amsterdam, North Holland, 1117 MB, Netherlands

RECRUITING

Red Cross Hospital

Beverwijk, North Holland, 1942 LE, Netherlands

RECRUITING

Spaarne Hospital

Hoofddorp, North Holland, 2134 TM, Netherlands

RECRUITING

Related Publications (1)

  • Bruntink MM, Groutars YME, Schipper IB, Breederveld RS, Tuinebreijer WE, Derksen RJ; PROTECT studygroup. Nadroparin or fondaparinux versus no thromboprophylaxis in patients immobilised in a below-knee plaster cast (PROTECT): A randomised controlled trial. Injury. 2017 Apr;48(4):936-940. doi: 10.1016/j.injury.2017.02.018. Epub 2017 Feb 22.

    PMID: 28279428DERIVED

MeSH Terms

Conditions

Venous ThrombosisPulmonary EmbolismAnkle Fractures

Interventions

NadroparinFondaparinux

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismFractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydratesOligosaccharides

Study Officials

  • Roelf S Breederveld, MD, PhD

    Red Cross Hospital Beverwijk

    STUDY DIRECTOR

  • Yannick M Groutars, MD

    Red Cross Hospital Beverwijk

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert J Derksen, MD, PhD

CONTACT

+31 6 24748122rjderksen@hotmail.com

Roelf S Breederveld, MD, PhD

CONTACT

+31 251 264920breed@kpnplanet.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 15, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

December 18, 2012

Record last verified: 2009-05

Locations

NL(5)