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Clinical Trial
Journal Article
Randomized Controlled Trial
A randomized, prospective trial of deep venous thrombosis prophylaxis in aortic surgery.
Archives of Surgery 1997 May
OBJECTIVES: To study the incidence of postoperative deep venous thrombosis (DVT) in patients undergoing elective aortic reconstruction and to determine if aggressive DVT prophylaxis would reduce the incidence of DVT in these patients.
DESIGN: Randomized, prospective trial.
SETTING: University hospital and Veterans Affairs hospital.
PATIENTS: One hundred patients undergoing aortic reconstruction for aneurysmal or occlusive disease randomized to receive DVT prophylaxis (treatment group) or no prophylaxis (control group). Exclusion criteria included a history of DVT, long-term anticoagulant use, or a malignant neoplasm. During the study period, 12 patients were ineligible for follow-up. Ninety-eight patients completed the trial, including 50 patients in the treatment group and 48 patients in the control group. Two patients in the control group died postoperatively of unrelated causes.
INTERVENTION: Patients in the treatment group received DVT prophylaxis using a combination of low-dose heparin sodium therapy (5000 U every 12 hours) and calf-length intermittent mechanical compression devices. Control patients received no DVT prophylaxis.
MAIN OUTCOME MEASURES: The occurrence of acute lower extremity DVT diagnosed by interval venous duplex ultrasound scan surveillance performed on postoperative days 1, 3, and 7.
RESULTS: The overall incidence of proximal DVT in this study was 2%. One case of DVT occurred in the treatment group, and the other one occurred in the control group. There was no statistically significant difference (P = .99) in the incidence of DVT between the 2 groups. One patients in the control group had a nonfatal pulmonary embolus (1% of the patients overall).
CONCLUSIONS: The incidence of proximal DVT in patients undergoing elective aortic reconstruction is low compared with patients undergoing other major intraabdominal general surgical procedures. The use of aggressive DVT prophylaxis did not reduce the risk of postoperative proximal DVT in this study. The selective use of DVT prophylaxis in patients undergoing elective aortic surgery should be based on associated concomitant or evolving risk factors.
DESIGN: Randomized, prospective trial.
SETTING: University hospital and Veterans Affairs hospital.
PATIENTS: One hundred patients undergoing aortic reconstruction for aneurysmal or occlusive disease randomized to receive DVT prophylaxis (treatment group) or no prophylaxis (control group). Exclusion criteria included a history of DVT, long-term anticoagulant use, or a malignant neoplasm. During the study period, 12 patients were ineligible for follow-up. Ninety-eight patients completed the trial, including 50 patients in the treatment group and 48 patients in the control group. Two patients in the control group died postoperatively of unrelated causes.
INTERVENTION: Patients in the treatment group received DVT prophylaxis using a combination of low-dose heparin sodium therapy (5000 U every 12 hours) and calf-length intermittent mechanical compression devices. Control patients received no DVT prophylaxis.
MAIN OUTCOME MEASURES: The occurrence of acute lower extremity DVT diagnosed by interval venous duplex ultrasound scan surveillance performed on postoperative days 1, 3, and 7.
RESULTS: The overall incidence of proximal DVT in this study was 2%. One case of DVT occurred in the treatment group, and the other one occurred in the control group. There was no statistically significant difference (P = .99) in the incidence of DVT between the 2 groups. One patients in the control group had a nonfatal pulmonary embolus (1% of the patients overall).
CONCLUSIONS: The incidence of proximal DVT in patients undergoing elective aortic reconstruction is low compared with patients undergoing other major intraabdominal general surgical procedures. The use of aggressive DVT prophylaxis did not reduce the risk of postoperative proximal DVT in this study. The selective use of DVT prophylaxis in patients undergoing elective aortic surgery should be based on associated concomitant or evolving risk factors.
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