Nadroparin or fondaparinux versus no thromboprophylaxis in patients immobilised in a below-knee plaster cast (PROTECT): A randomised controlled trial

Marlieke M. Bruntink, Yannick M.E. Groutars, Inger B. Schipper, Roelf S. Breederveld, Wim E. Tuinebreijer, Robert J. Derksen, PROTECT studygroup

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background The immobilisation of the lower leg is associated with deep vein thrombosis (DVT). However, thromboprophylaxis in patients with a below-knee plaster cast remains controversial. We examined the efficacy and safety of nadroparin and fondaparinux to ascertain the need for thromboprophylaxis in these patients. Methods PROTECT was a randomised, controlled, single-blind, multicentre study that enrolled adults with an ankle or foot fracture who required immobilisation for a minimum of four weeks. The patients were randomly assigned (1:1:1) to a control group (no thromboprophylaxis) or to one of the intervention groups: daily subcutaneous self-injection of either nadroparin (2850 IE anti-Xa = 0.3 ml) or fondaparinux (2.5 mg = 0.5 ml). A venous duplex sonography was performed after the removal of the cast or earlier if thrombosis was suspected. The primary outcome was the relative risk of developing DVT in the control group compared with that in both intervention groups. This trial is registered at ClinicalTrials.gov, number NCT00881088. Results Between April 2009 and December 2015, 467 patients were enrolled and assigned to either the nadroparin group (n = 154), the fondaparinux group (n = 157), or the control group (n = 156). A total of 273 patients (92, 92, and 94 patients, respectively) were analysed. The incidence of DVT in the nadroparin group was 2/92 (2.2%) compared with 11/94 (11.7%) in the control group, with a relative risk of 5.4 (95% CI 1.2–23.6; p = 0.011). The incidence of DVT in the fondaparinux group was 1/92 (1.1%), yielding a relative risk of 10.8 (95% CI 1.4–80.7; p = 0.003) compared with that in the control group. No major complications occurred in any group. Conclusion Thromboprophylaxis with nadroparin or fondaparinux significantly reduces the risk of DVT in patients with an ankle or foot fracture who were treated in a below-knee cast without any major adverse events.

Original languageEnglish
Pages (from-to)936-940
Number of pages5
JournalInjury
Volume48
Issue number4
DOIs
Publication statusPublished - 1 Apr 2017

Cite this

Bruntink, Marlieke M. ; Groutars, Yannick M.E. ; Schipper, Inger B. ; Breederveld, Roelf S. ; Tuinebreijer, Wim E. ; Derksen, Robert J. ; PROTECT studygroup. / Nadroparin or fondaparinux versus no thromboprophylaxis in patients immobilised in a below-knee plaster cast (PROTECT) : A randomised controlled trial. In: Injury. 2017 ; Vol. 48, No. 4. pp. 936-940.
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title = "Nadroparin or fondaparinux versus no thromboprophylaxis in patients immobilised in a below-knee plaster cast (PROTECT): A randomised controlled trial",
abstract = "Background The immobilisation of the lower leg is associated with deep vein thrombosis (DVT). However, thromboprophylaxis in patients with a below-knee plaster cast remains controversial. We examined the efficacy and safety of nadroparin and fondaparinux to ascertain the need for thromboprophylaxis in these patients. Methods PROTECT was a randomised, controlled, single-blind, multicentre study that enrolled adults with an ankle or foot fracture who required immobilisation for a minimum of four weeks. The patients were randomly assigned (1:1:1) to a control group (no thromboprophylaxis) or to one of the intervention groups: daily subcutaneous self-injection of either nadroparin (2850 IE anti-Xa = 0.3 ml) or fondaparinux (2.5 mg = 0.5 ml). A venous duplex sonography was performed after the removal of the cast or earlier if thrombosis was suspected. The primary outcome was the relative risk of developing DVT in the control group compared with that in both intervention groups. This trial is registered at ClinicalTrials.gov, number NCT00881088. Results Between April 2009 and December 2015, 467 patients were enrolled and assigned to either the nadroparin group (n = 154), the fondaparinux group (n = 157), or the control group (n = 156). A total of 273 patients (92, 92, and 94 patients, respectively) were analysed. The incidence of DVT in the nadroparin group was 2/92 (2.2{\%}) compared with 11/94 (11.7{\%}) in the control group, with a relative risk of 5.4 (95{\%} CI 1.2–23.6; p = 0.011). The incidence of DVT in the fondaparinux group was 1/92 (1.1{\%}), yielding a relative risk of 10.8 (95{\%} CI 1.4–80.7; p = 0.003) compared with that in the control group. No major complications occurred in any group. Conclusion Thromboprophylaxis with nadroparin or fondaparinux significantly reduces the risk of DVT in patients with an ankle or foot fracture who were treated in a below-knee cast without any major adverse events.",
keywords = "Deep vein thrombosis, Fracture, Lower leg immobilisation, Thromboprophylaxis, Venous thromboembolic event",
author = "Bruntink, {Marlieke M.} and Groutars, {Yannick M.E.} and Schipper, {Inger B.} and Breederveld, {Roelf S.} and Tuinebreijer, {Wim E.} and Derksen, {Robert J.} and America, {O. Willemijn M.} and {van den Berg}, Wendy and Bevort, {Adrien H.} and Bilars, {Peter M.} and Bloemers, {Frank W.} and {van den Brand}, {Johan G.H.} and Clous, {Emile A.} and Cathelijne Duijzer and Jels Fongers and Fr{\"o}lke, {Jan Paul M.} and Merle Huizenga and Lobke Ruys and Sosef, {Nico L.} and Werkman, {Jorien M.} and {de Wijs}, {Mariska J.D.} and {van Wulfften Palthe}, {Alexander F.Y.} and Bijlsma, {Taco S.} and {PROTECT studygroup}",
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Nadroparin or fondaparinux versus no thromboprophylaxis in patients immobilised in a below-knee plaster cast (PROTECT) : A randomised controlled trial. / Bruntink, Marlieke M.; Groutars, Yannick M.E.; Schipper, Inger B.; Breederveld, Roelf S.; Tuinebreijer, Wim E.; Derksen, Robert J.; PROTECT studygroup.

In: Injury, Vol. 48, No. 4, 01.04.2017, p. 936-940.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Nadroparin or fondaparinux versus no thromboprophylaxis in patients immobilised in a below-knee plaster cast (PROTECT)

T2 - A randomised controlled trial

AU - Bruntink, Marlieke M.

AU - Groutars, Yannick M.E.

AU - Schipper, Inger B.

AU - Breederveld, Roelf S.

AU - Tuinebreijer, Wim E.

AU - Derksen, Robert J.

AU - America, O. Willemijn M.

AU - van den Berg, Wendy

AU - Bevort, Adrien H.

AU - Bilars, Peter M.

AU - Bloemers, Frank W.

AU - van den Brand, Johan G.H.

AU - Clous, Emile A.

AU - Duijzer, Cathelijne

AU - Fongers, Jels

AU - Frölke, Jan Paul M.

AU - Huizenga, Merle

AU - Ruys, Lobke

AU - Sosef, Nico L.

AU - Werkman, Jorien M.

AU - de Wijs, Mariska J.D.

AU - van Wulfften Palthe, Alexander F.Y.

AU - Bijlsma, Taco S.

AU - PROTECT studygroup

PY - 2017/4/1

Y1 - 2017/4/1

N2 - Background The immobilisation of the lower leg is associated with deep vein thrombosis (DVT). However, thromboprophylaxis in patients with a below-knee plaster cast remains controversial. We examined the efficacy and safety of nadroparin and fondaparinux to ascertain the need for thromboprophylaxis in these patients. Methods PROTECT was a randomised, controlled, single-blind, multicentre study that enrolled adults with an ankle or foot fracture who required immobilisation for a minimum of four weeks. The patients were randomly assigned (1:1:1) to a control group (no thromboprophylaxis) or to one of the intervention groups: daily subcutaneous self-injection of either nadroparin (2850 IE anti-Xa = 0.3 ml) or fondaparinux (2.5 mg = 0.5 ml). A venous duplex sonography was performed after the removal of the cast or earlier if thrombosis was suspected. The primary outcome was the relative risk of developing DVT in the control group compared with that in both intervention groups. This trial is registered at ClinicalTrials.gov, number NCT00881088. Results Between April 2009 and December 2015, 467 patients were enrolled and assigned to either the nadroparin group (n = 154), the fondaparinux group (n = 157), or the control group (n = 156). A total of 273 patients (92, 92, and 94 patients, respectively) were analysed. The incidence of DVT in the nadroparin group was 2/92 (2.2%) compared with 11/94 (11.7%) in the control group, with a relative risk of 5.4 (95% CI 1.2–23.6; p = 0.011). The incidence of DVT in the fondaparinux group was 1/92 (1.1%), yielding a relative risk of 10.8 (95% CI 1.4–80.7; p = 0.003) compared with that in the control group. No major complications occurred in any group. Conclusion Thromboprophylaxis with nadroparin or fondaparinux significantly reduces the risk of DVT in patients with an ankle or foot fracture who were treated in a below-knee cast without any major adverse events.

AB - Background The immobilisation of the lower leg is associated with deep vein thrombosis (DVT). However, thromboprophylaxis in patients with a below-knee plaster cast remains controversial. We examined the efficacy and safety of nadroparin and fondaparinux to ascertain the need for thromboprophylaxis in these patients. Methods PROTECT was a randomised, controlled, single-blind, multicentre study that enrolled adults with an ankle or foot fracture who required immobilisation for a minimum of four weeks. The patients were randomly assigned (1:1:1) to a control group (no thromboprophylaxis) or to one of the intervention groups: daily subcutaneous self-injection of either nadroparin (2850 IE anti-Xa = 0.3 ml) or fondaparinux (2.5 mg = 0.5 ml). A venous duplex sonography was performed after the removal of the cast or earlier if thrombosis was suspected. The primary outcome was the relative risk of developing DVT in the control group compared with that in both intervention groups. This trial is registered at ClinicalTrials.gov, number NCT00881088. Results Between April 2009 and December 2015, 467 patients were enrolled and assigned to either the nadroparin group (n = 154), the fondaparinux group (n = 157), or the control group (n = 156). A total of 273 patients (92, 92, and 94 patients, respectively) were analysed. The incidence of DVT in the nadroparin group was 2/92 (2.2%) compared with 11/94 (11.7%) in the control group, with a relative risk of 5.4 (95% CI 1.2–23.6; p = 0.011). The incidence of DVT in the fondaparinux group was 1/92 (1.1%), yielding a relative risk of 10.8 (95% CI 1.4–80.7; p = 0.003) compared with that in the control group. No major complications occurred in any group. Conclusion Thromboprophylaxis with nadroparin or fondaparinux significantly reduces the risk of DVT in patients with an ankle or foot fracture who were treated in a below-knee cast without any major adverse events.

KW - Deep vein thrombosis

KW - Fracture

KW - Lower leg immobilisation

KW - Thromboprophylaxis

KW - Venous thromboembolic event

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U2 - 10.1016/j.injury.2017.02.018

DO - 10.1016/j.injury.2017.02.018

M3 - Article

VL - 48

SP - 936

EP - 940

JO - Injury. International Journal of the Care of the Injured

JF - Injury. International Journal of the Care of the Injured

SN - 0020-1383

IS - 4

ER -