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

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.

Timeline

Start

2009-04

Primary completion

2013-04

Completion

2013-04

Outcome

Met primary endpoint

paper 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) PMID 28279428 ↗

paper Thromboprophylaxis with nadroparin or fondaparinux significantly reduces the risk of DVT in patients with an ankle or foot fracture PMID 28279428 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fondaparinux	Other / unclassified	2.5 mg	Subcutaneous
Subject	Nadroparin Calcium	Other / unclassified	2850 iu	Subcutaneous

Indications