Prophylaxis of Thromboembolic Complications Trial: Thromboprophylaxis Needed in Below Knee Plaster Cast Immobilization for Ankle and Foot Fractures (PROTECT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Red Cross Hospital Beverwijk.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
R.J. Derksen, Red Cross Hospital Beverwijk
ClinicalTrials.gov Identifier:
NCT00881088
First received: April 13, 2009
Last updated: December 15, 2012
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Deep Vein Thrombosis
Pulmonary Embolism
Drug: Nadroparin
Drug: Fondaparinux
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylaxis of Venous Thromboembolism in Patients With a Nonsurgical Fracture of the Lower Extremity Immobilised in a Below-Knee Plaster Cast

Resource links provided by NLM:


Further study details as provided by Red Cross Hospital Beverwijk:

Primary Outcome Measures:
  • Primary outcome measure is deep vein trombosis as detected by venous duplex [ Time Frame: subjects are assessed after 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleeding complications [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 669
Study Start Date: April 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Patients randomized to the no intervention group
Experimental: Nadroparin
Subjects randomized to group receiving nadroparin 0,3 cc daily during immobilization
Drug: Nadroparin
nadroparin 0,3 cc once daily during immobilization period
Other Name: Fraxiparin
Experimental: Fondaparinux
Subjects randomized to fondaparinux 2,5 mg daily group during immobilization
Drug: Fondaparinux
Fondaparinux 2,5 mg daily during immobilization period
Other Name: Arixtra

Detailed Description:

Study Design:

A prospective, randomised, controlled, single blinded, multi-centre trial.

Intervention:

After meeting the inclusion criteria stated above and obtaining informed consent, patients will be randomly assigned to three groups: one receiving Nadroparine (2850 IE anti-Xa = 0,3 ml, given once daily), one receiving Fondaparinux (2,5 mg = 0,5 ml, given once daily) and one receiving no prophylaxis. These dosages are standard for the use in thromboprophylaxis. The first two groups will be instructed by a trained nurse in subcutaneous self-injection of the medicine and will be given pre-filled disposable syringes for once-daily administration for the duration of immobilisation.

In the light of current scientific knowledge a placebo effect of subcutaneous injections of saline in the control group is implausible since the outcome measure (colour duplex sonography) is an objective one.

Patients further will receive a letter explaining the symptoms suggesting the development of deep-vein thrombosis, pulmonary embolism and adverse events and will be asked to contact the emergency room when any of these would occur.

All patient-information will be coded so that it cannot be traced back to the individual patient. This coded information can be used for publication.

Outcome:

At the time of removal of the plaster cast symptoms or signs suggestive of DVT will be noted and a colour duplex ultrasonography of the treated limb will be performed in all patients by an experienced technician according to a strict diagnostic test protocol (see enclosure 1). When there is incompressibility of a vein or lack of flow the diagnosis of DVT is made. The technician will be blinded to treatment.

In case of a suspected pulmonary embolism pulmonary angiography will be performed.

The following risk-factors for DVT will be recorded: age, sex, body mass index (BMI), current smoking, use of estrogen-containing hormonal replacement therapy or oral contraception, active cancer (treatment on going or stopped for less than one year), congenital or acquired hypercoagulable state, previous deep venous thromboembolism and varicose veins.

Safety will be assessed as a secondary outcome. Adverse events such as haematomas, bleeding and allergic reactions will be recorded.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Severe head injury within the previous three months
  • Intraocular, spinal, and/or brain surgery within the previous twelve months
  • Major surgery within the previous two months
  • Treatment with LMWH or other anticoagulants
  • Anticoagulant therapy required or likely to be required during the study period (e.g. planned surgery justifying pharmacological thromboprophylaxis)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881088

Contacts
Contact: Robert J Derksen, MD, PhD +31 6 24748122 rjderksen@hotmail.com
Contact: Roelf S Breederveld, MD, PhD +31 251 264920 breed@kpnplanet.nl

Locations
Netherlands
University Medical Center Nijmegen Recruiting
Nijmegen, Gelderland, Netherlands
Contact: Jan Paul Frolke, MD, PhD         
VU University Medical Center Recruiting
Amsterdam, N-Holland, Netherlands, 1117 MB
Contact: Fred C Bakker, MD, PhD    +31 20 4444444 ext 097    fc.bakker@vumc.nl   
Contact: Jels Fongers, MD    +31 20 4443636    J.Fongers@vumc.nl   
Red Cross Hospital Recruiting
Beverwijk, N-Holland, Netherlands, 1942 LE
Contact: Robert J Derksen, MD, PhD    +31 6 24748122    rjderksen@hotmail.com   
Contact: Roelf S Breederveld, MD, PhD    +31251264920      
Medical Center Alkmaar Recruiting
Alkmaar, North Holland, Netherlands, 1815 JD
Contact: J H van der Brand, MD, PhD         
Spaarne Hospital Recruiting
Hoofddorp, North Holland, Netherlands, 2134 TM
Contact: Nico Sosef, MD         
Sponsors and Collaborators
Red Cross Hospital Beverwijk
Investigators
Study Director: Roelf S Breederveld, MD, PhD Red Cross Hospital Beverwijk
Principal Investigator: Yannick M Groutars, MD Red Cross Hospital Beverwijk
  More Information

Additional Information:
No publications provided

Responsible Party: R.J. Derksen, Principal investigator, Red Cross Hospital Beverwijk
ClinicalTrials.gov Identifier: NCT00881088     History of Changes
Other Study ID Numbers: PROTECT
Study First Received: April 13, 2009
Last Updated: December 15, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Red Cross Hospital Beverwijk:
Deep vein trombosis
Profylaxis
Below knee plaster cast
Ankle fracture

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism
Fondaparinux
PENTA
Nadroparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 18, 2014