Ramacciotti study - description and results

in hospital intravenous bolus injection of 5000 IU of UFH followed by intravenous 500 IU/kg/day adjusted to maintain an aPTT of 1.5-2.5 times the normal value for 5-10 days.

Remarks

warfarin (with a targeted INR 2-3) for at least 3 months, starting at day 1 or 2 of treatment.

Patients

patienst with DVT symptoms for greater than or equal to 10 days and proximal lower limb DVT confirmed by duplex ultrasound or venography

Inclusion criteria

Age greater than or equal to 18 years, weight greater than or equal to 50 and

Exclusion criteria

History of HIT or allergy to heparin, haemorrhagic diathesis, surgery within 7 days, symptoms of PE, bilateral DVT, survival prognaosis 3days, initial platelet count 1.3 time the normal value, INR> 1.5 at enrollment, indication for thrombolysis or venous thrombectomy

Results

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

Recurrent thromboembolic event

2 / 104
7 / 97
0,27 [0,06;1,25]

Minor bleeding

12 / 104
9 / 97
classic 1,24 [0,55;2,82]

Major bleeding

2 / 104
2 / 97
classic 0,93 [0,13;6,49]

All cause death

0 / 104
0 / 97
classic 0,93 [0,00;236,78] 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	2 / 104 (1,9%)	7 / 97 (7,2%)	0,27	[0,06;1,25]
Minor bleeding	12 / 104 (11,5%)	9 / 97 (9,3%)	1,24	[0,55;2,82]
Major bleeding	2 / 104 (1,9%)	2 / 97 (2,1%)	0,93	[0,13;6,49]
All cause death	0 / 104 (0,5%)	0 / 97 (0,5%)	0,93	[0,02;46,55]
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	1,92%	7,22%	-52,9‰
Minor bleeding	11,54%	9,28%	2,3%
Major bleeding	1,92%	2,06%	-1,4‰

Reference(s)

Trials register #

Ramacciotti E, Araújo GR, Lastoria S, Maffei FH, Karaoglan de Moura L, Michaelis W, Sandri JL, Dietrich-Neto F. An open-label, comparative study of the efficacy and safety of once-daily dose of enoxaparin versus unfractionated heparin in the treatment of proximal lower limb deep-vein thrombosis.. Thromb Res 2004;114:149-53

Pubmed | Hubmed | Fulltext

Ramacciotti study, 2004

Treatments

Patients

Method and design

Results

Reference(s)