Daskalopoulos study - description and results

Related trials

Treatments

Studied treatment

home treatment with single sub- cutaneous injection of LMWH (tinzaparin sodium) in a weight adjusted dose (175 anti Xa IU/Kg) daily for 6 months

Control treatment

Intravenous bolus of 5000IU UFH followed by intrvenous infusion of UFH for 5-7 days. APTT was measured after 4 hours of the initiation of heparin administration and was repeated 6 hours thereafter to reach the therapeutic range (ratio: 1.5-2.5). Oral an

Patients

patients with acute proximal DVT confirmed by colour duplex UScan not more than 1 week onset

Exclusion criteria

Segmental deep venous thrombosis restricted to infrapopliteal deep veins or calfmuscles as determined by duplex ultrasonography, symptomatic or clinically suspected PE, history of recently diagnosed (within 12 months) DVT or PE, patient already on anticoagulant therapy, bleeding tendency objectively confirmed, hypersensitivity to heparin preparations or coumarin derivatives, uncontrolled hypertension, history of recently diagnosed (less than 1 month) cerebrovascular accident, intracranial artery aneurysm, infectious endocarditis, thrombocytopenia, active peptic ulcer, hepatic or renal failure, history of asthma, recent spinal or epidural anaesthesia or intraspinal paracentesis (less than 5 days), recent surgery (less than 5 days), recently performed thrombolysis or under antiplatelet therapy, body weight less than 35kg, pregnancy,illicit drug addiction, altered mental status or impaired cognitive function with inability to comply with study protocol

Results

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

Recurrent thromboembolic event

5 / 55
6 / 53
classic 0,80 [0,26;2,47]

Minor bleeding

3 / 55
3 / 53
classic 0,96 [0,20;4,56]

Major bleeding

2 / 55
4 / 53
classic 0,48 [0,09;2,52]

All cause death

1 / 55
2 / 53
classic 0,48 [0,05;5,16] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial
Recurrent thromboembolic event	5 / 55 (9,1%)	6 / 53 (11,3%)	0,80	[0,26;2,47]
Minor bleeding	3 / 55 (5,5%)	3 / 53 (5,7%)	0,96	[0,20;4,56]
Major bleeding	2 / 55 (3,6%)	4 / 53 (7,5%)	0,48	[0,09;2,52]
All cause death	1 / 55 (1,8%)	2 / 53 (3,8%)	0,48	[0,05;5,16]
The primary endpoint (if exists) appears in blod characters

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
Recurrent thromboembolic event	9,09%	11,32%	-22,3‰
Minor bleeding	5,45%	5,66%	-2,1‰
Major bleeding	3,64%	7,55%	-39,1‰
All cause death	1,82%	3,77%	-19,6‰

Reference(s)

Trials register #

Daskalopoulos ME, Daskalopoulou SS, Tzortzis E, Sfiridis P, Nikolaou A, Dimitroulis D, Kakissis I, Liapis CD. Long-term treatment of deep venous thrombosis with a low molecular weight heparin (tinzaparin): a prospective randomized trial.. Eur J Vasc Endovasc Surg 2005;29:638-50

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Daskalopoulos study, 2005

Treatments

Patients

Method and design

Results

Reference(s)

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