Adjusted subcutaneous heparin or continuous intravenous heparin in patients with acute deep vein thrombosis. A randomized trial.
OBJECTIVE
To determine the efficacy and safety of adjusted subcutaneous calcium heparin compared with continuous intravenous calcium heparin as the initial treatment for acute deep vein thrombosis.


METHODS
Randomized control trial.


METHODS
University-affiliated general hospital.


METHODS
Of 111 consecutive patients considered, 103 had acute proximal or calf vein thrombosis confirmed by ascending venography and met all other eligibility criteria.


METHODS
PATIENTS were randomly assigned to receive subcutaneous or intravenous heparin. The subcutaneous regimen consisted of an initial dose of 15,000 U, adjusted thereafter to prolong the activated partial thromboplastin time to 50 to 70 seconds. The continuous intravenous regimen was begun as a bolus injection of 5000 U, followed by an infusion of 1250 U/h, adjusted to maintain the activated partial thromboplastin time at 50 to 70 seconds.


RESULTS
There was no significant difference in the rate of new pulmonary embolism between the two groups, as defined by new high-probability defect on repeat ventilation-perfusion scintigrams of the lung in 96 (93%) of the patients after 7 to 10 days of treatment. Five of forty-seven patients in the subcutaneous group and 5 of 49 in the intravenous group developed pulmonary embolism (95% confidence interval [CI] for the difference, -13.1% to 12.2%). Similarly, there was no significant difference in the frequency of hemorrhagic complications. Five of fifty-one patients in the subcutaneous group and 5 of 52 in the intravenous group had hemorrhagic complications (95% CI for the difference, -11.2% to 11.6%).


CONCLUSIONS
Adjusted subcutaneous calcium heparin may be an effective and safe alternative to continuous intravenous calcium heparin in the initial treatment of acute proximal deep vein thrombosis.
Doyle
D J
DJ
Turpie
A G
AG
Hirsh
J
J
Best
C
C
Kinch
D
D
Levine
M N
MN
Gent
M
M
D000208:Acute Disease; D002986:Clinical Trials as Topic; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D010314:Partial Thromboplastin Time; D011655:Pulmonary Embolism / Q000000981:diagnostic imaging / Q000517:prevention & control; D011877:Radionuclide Imaging; D011897:Random Allocation; D013924:Thrombophlebitis / Q000150:complications / Q000188:drug therapy*
C006871:calcium heparin; D006493:Heparin