|- candidate number||5493|
|- NTR Number||NTR1733|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-mrt-2009|
|- Secondary IDs||23109/2008-004674-41 ABR/EudraCT |
|- Public Title||Prevention of thrombosis in patients who are treated with a plaster cast for a fracture of the ankle or foot.|
|- Scientific Title||PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN PATIENTS WITH A NONSURGICAL FRACTURE OF THE LOWER EXTREMITY IMMOBILISED IN A BELOW-KNEE PLASTER CAST.|
|- ACRONYM||PROTECT: Prophylaxis of Thromboembolic Complications Trial|
|- 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.|
|- Healt Condition(s) or Problem(s) studied||Thrombosis, Fracture |
|- Inclusion criteria||1. Age ¡Ý 18 years;|
2. # lower extremity;
3. Immobilisation in a below-knee plaster cast for a minimum of 4 weeks.
|- Exclusion criteria||1. Delay between injury and Emergency Department visit greater than three days;|
2. Pregnancy/ lactation;
3. Body weight < 50 kg;
4. History of venous thromboembolism;
6. Severe hepatic impairment;
7. Severe renal impairment;
8. Known hypersensitivity to nadroparine or fondaparinux;
9. Documented congenital or acquired bleeding tendency/disorder;
10. Active, clinically significant bleeding;
11. Clinically significant bleeding within the past six months;
12. Previous or active bleeding from the digestive tract by peptic ulcer, tumours, hiatus hernia or diverticulosis;
13. Severe hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg);
14. Haemorrhagic stroke within the previous two months;
15. Severe head injury within the previous three months;
16. Intraocular, spinal, and/or brain surgery within the previous twelve months;
17. Major surgery within the previous two months;
18. Treatment with LMWH or other anticoagulants;
19. Anticoagulant therapy required or likely to be required during the study period (e.g. planned surgery justifying pharmacological thromboprophylaxis).
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2009|
|- planned closingdate||1-apr-2011|
|- Target number of participants||669|
|- Interventions||1. 1 group no intervention (control group);|
2. 1 group receiving Nadroparine (2850 IE anti-Xa = 0,3 ml, given once daily);
3. 1 group receiving Fondaparinux (2,5 mg = 0,5 ml, given once daily).
|- Primary outcome||Venous thromboembolism (DVT or PE), assessed by colour duplex ultrasonography or pulmonary angiography. |
|- Secondary outcome||Adverse associated with the use of nadroparine or fondaparinux.|
|- Timepoints||The day of removal of the plaster cast.|
|- Trial web site||www.protectstudie.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Y. Groutars|
|- CONTACT for SCIENTIFIC QUERIES|| Y. Groutars|
|- Sponsor/Initiator ||Slotervaart Hospital, Spaarne Hospital, Noordwest Ziekenhuisgroep, Rode Kruis Hopital (Red Cross Hospital)|
(Source(s) of Monetary or Material Support)
|GlaxoSmithKline, Rode Kruis Ziekenhuis (Red Cross Hospital), Beverwijk|
|- Brief summary|| Although both trauma and immobilisation are two very well known risk factors in the development of deep vein thrombosis (DVT) no generally accepted strategy exists in dutch hospitals for patients being treated conservatively in a below-knee plaster for a fracture of a lower extremity.
Randomised controlled trials differ markedly in their conclusion with some trials advocating the use of LMWH and others advising against it. Also, patients being treated in a below-knee plaster cast have never been studied seperately. Therefore these conclusions are difficult to use for this specific group.
Both symptomatic and asymptomatic DVT can give rise to substantial morbidity and mortality, like post-thrombotic syndrome (PTS) and pulmonary embolism (PE).
For years, the low-molecular-weight heparins have been considered to be the most effective and safest form of prevention of venous thromboembolism in patients requiring a relative short period of prophylaxis. However, a number of large recent studies have shown that fondaparinux is more effective in the prevention of DVT without increasing the risk of side-effects.
The purpose of this study is to determine the need for thromboprofylaxis in patients being treated in a below-knee plaster cast after trauma of a lower extremity and if there is, to assess if both of the two tested prophylactic treatments are suited for this indication.
|- Main changes (audit trail)|
|- RECORD||23-mrt-2009 - 14-sep-2009|