NCT00796692.

Trial name or title	Nadroparin for the Initial Treatment of Pulmonary Thromboembolism (NATSPUTE)
Methods	Multicentre, randomised, open‐label, parallel assignment controlled trial
Participants	Inclusion criteria: 18 to 75 years of age, symptomatic non‐massive PTE confirmed either by high probability ventilation‐perfusion lung scanning (V/Q scan) or by the presence of intraluminal filling defect on spiral computed tomographic pulmonary angiography (CTPA), haemodynamically stabile, anatomic obstruction no more than 2 lobes on CTPA, or defect no more than 7 segments on V/Q scan, and normal right ventricular function, symptoms within 15 days, written informed consent obtained before randomisation. Exclusion criteria: unfractionated heparin anticoagulation for more than 36 hours prior enrolment, massive PTE or sub‐massive PTE requiring thrombolytic therapy or pulmonary embolectomy, active bleeding or disorders contraindicating anticoagulant therapy, chronic thromboembolism pulmonary hypertension (CTEPH) without evidence of recent episode, severe hepatic or renal failure, allergy to heparin, other components of tinzaparin or acenocoumarol, pregnant status, a life expectancy of less than 3 months, previous thrombocytopaenia induced by heparin, thrombocytopaenia < 100,000/mm³.
Interventions	Treatment: LMWH given with a weight‐adjusted dose of 86 international anti‐factor Xa units of nadroparin (Fraxiparine) per kilogram of body weight (86 anti‐factor Xa IU/kg) subcutaneously every 12 hours, which will be used at least 5 to 7 days. Control: UFH is received with an initial bolus dose of 80 IU per kilogram, followed by a continuous intravenous infusion at an initial rate of 18 IU per kilogram per hour. The dose is subsequently adjusted so that the activated partial thromboplastin time (APTT) would be 1.5 to 2.5 times the control value in normal subjects. The tests are performed 4 hours after the start of treatment, whenever a sub‐therapeutic APTT had been measured after a dose adjustment, and otherwise daily. UFH will be used at least 5 to 7 days. Treatment duration: 5 to 7 days. Oral anticoagulation: warfarin.
Outcomes	Primary: clinical and image (including V/Q scan and CTPA) improvement at 14 days. Secondary: recurrent venous thromboembolism (VTE), major bleeding, death and heparin‐induced thrombocytopaenia at 3 months.
Starting date	June 2002
Contact information	Professor Chen Wang, Beijing Institute of Respiratory Medicine, Beijing Chao Yang Hospital, China
Notes	Study authors have been contacted for further information but no response received to date

IU: international units
 kg: kilogram
 LMWH: low molecular weight heparin
 mm: millimetre
 PTE: pulmonary thromboembolism
 UFH: unfractionated heparin