Deep Vein ThrombosisPhase 2/3PROTECTNCT00881088
Prophylaxis of Thromboembolic Complications Trial: Thromboprophylaxis Needed in Below Knee Plaster Cast Immobilization for Ankle and Foot Fractures
A Phase 2/3 study testing Nadroparin and Fondaparinux in people with Deep Vein Thrombosis and Pulmonary Embolism, run by Red Cross Hospital Beverwijk at 5 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolism
- What is being tested?
- Nadroparin and Fondaparinux
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 669 participants
- Where
- 5 sitesNetherlands
- Study dates
- Apr 2009to Apr 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Recruiting
Medical Center Alkmaar
Alkmaar, North Holland, 1815 JD
J H van der Brand, MD, PhD
- Recruiting
VU University Medical Center
Amsterdam, North Holland, 1117 MB
Fred C Bakker, MD, PhD, +31 20 4444444 ext. 097, fc.bakker@vumc.nl
Jels Fongers, MD, +31 20 4443636, J.Fongers@vumc.nl
- Recruiting
Red Cross Hospital
Beverwijk, North Holland, 1942 LE
Robert J Derksen, MD, PhD, +31 6 24748122, rjderksen@hotmail.com
Roelf S Breederveld, MD, PhD, +31251264920
- Recruiting
Spaarne Hospital
Hoofddorp, North Holland, 2134 TM
Nico Sosef, MD
- Recruiting
University Medical Center Nijmegen
Nijmegen, Gelderland
Jan Paul Frolke, MD, PhD
About this study
Official title: Prophylaxis of Venous Thromboembolism in Patients With a Nonsurgical Fracture of the Lower Extremity Immobilised in a Below-Knee Plaster Cast
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.
Read the 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.
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Being tested
- Nadroparin, Fondaparinux
- Keywords
- Deep vein trombosis, Profylaxis, Below knee plaster cast, Ankle fracture
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NadroparinDrug
Also called Fraxiparin
nadroparin 0,3 cc once daily during immobilization period
FondaparinuxDrug
Also called Arixtra
Fondaparinux 2,5 mg daily during immobilization period
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Patients randomized to the no intervention group |
| Nadroparin | Experimental | Subjects randomized to group receiving nadroparin 0,3 cc daily during immobilization Receives: Drug: Nadroparin |
| Fondaparinux | Experimental | Subjects randomized to fondaparinux 2,5 mg daily group during immobilization Receives: Drug: Fondaparinux |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure is deep vein trombosis as detected by venous duplex
Measured: subjects are assessed after 6 weeks
Secondary outcomes (1)
Bleeding complications
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 669 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Red Cross Hospital Beverwijk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R.J. Derksen, Red Cross Hospital Beverwijk
- Investigators
- Roelf S Breederveld, MD, PhD, Study director, Red Cross Hospital BeverwijkYannick M Groutars, MD, Principal investigator, Red Cross Hospital Beverwijk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881088
- Sponsor's protocol ID
- PROTECT
- Acronym
- PROTECT
- Status last verified
- May 2009
- First submitted
- 13 Apr 2009
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28279428
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis of Venous Thromboembolism in Patients With a Nonsurgical Fracture of the Lower Extremity Immobilised in a Below-Knee Plaster Cast
- ClinicalTrials.gov ID
- NCT00881088
- Acronym / sponsor ID
- PROTECT / PROTECT
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Keywords
- Deep vein trombosis, Profylaxis, Below knee plaster cast, Ankle fracture
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 669 participants (estimated)
- Lead sponsor
- Red Cross Hospital BeverwijkUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 15 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Patients randomized to the no intervention group |
| Nadroparin | Experimental | Drug: NadroparinSubjects randomized to group receiving nadroparin 0,3 cc daily during immobilization |
| Fondaparinux | Experimental | Drug: FondaparinuxSubjects randomized to fondaparinux 2,5 mg daily group during immobilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NadroparinAlso: Fraxiparinnadroparin 0,3 cc once daily during immobilization period | Drug | Nadroparin |
| FondaparinuxAlso: ArixtraFondaparinux 2,5 mg daily during immobilization period | Drug | Fondaparinux |
Primary outcome
Primary outcome measure is deep vein trombosis as detected by venous duplex
Time frame: subjects are assessed after 6 weeks
1 secondary outcome
Bleeding complications
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
- Derived from this study: PubMed 28279428Bruntink 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roelf S Breederveld, MD, PhD study director
Red Cross Hospital Beverwijk
Yannick M Groutars, MD principal investigator
Red Cross Hospital Beverwijk
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nadroparin and Fondaparinux in people with Deep Vein Thrombosis and Pulmonary Embolism, run by Red Cross Hospital Beverwijk at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert J Derksen, MD, PhD (+31 6 24748122, rjderksen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure is deep vein trombosis as detected by venous duplex (time frame: subjects are assessed after 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00881088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.