Randomized, pilot study of intermittent pneumatic compression devices plus dalteparin versus intermittent pneumatic compression devices plus heparin for prevention of venous thromboembolism in patients undergoing craniotomy.

BACKGROUND: Unfractionated heparin and the low molecular weight heparin, dalteparin, are used for prophylaxis against venous thromboembolism in patients undergoing craniotomy. These drugs were compared in a randomized, prospective pilot study comparing intermittent pneumatic compression devices plus dalteparin to intermittent pneumatic compression devices plus heparin.
METHODS: One hundred patients undergoing craniotomy were randomly allocated to receive perioperative prophylaxis with subcutaneous (SC heparin, 5000 units every 12 hours, or dalteparin, 2,500 units once a day, begun at induction of anesthesia and continued for 7 days or until the patient was ambulating. Entry criteria were age over 18 years, no deep vein thrombosis (DVT) preoperatively as judged by lower limb duplex ultrasound and no clinical evidence of pulmonary embolism preoperatively. Patients with hypersensitivity to heparin, penetrating head injury or who refused informed consent were excluded. Patients underwent a duplex study 1 week after surgery and 1 month clinical follow-up. All patients were treated with lower limb intermittent pneumatic compression devices.
RESULTS: There were no differences between groups in age, gender, and risk factors for venous thromboembolism. There were no differences between groups in intraoperative blood loss, transfusion requirements or postoperative platelet counts. Two patients receiving dalteparin developed DVT (one symptomatic and one asymptomatic). No patient treated with heparin developed DVT and no patient in either group developed pulmonary embolism. There were two hemorrhages that did not require repeat craniotomy in patients receiving dalteparin and one that did require surgical evacuation in a patient treated with heparin. Drug was stopped in two patients treated with dalteparin because of thrombocytopenia. None of these differences were statistically significant.
CONCLUSION: There was no significant difference in postoperative hemorrhage, venous thromboembolism or thrombocytopenia between heparin and dalteparin. The results suggest that, given the small sample size of this trial, both drugs appear to be safe and the incidence of venous thromboembolism by postoperative screening duplex ultrasound appears to be low when these agents are used in combination with intermittent pneumatic compression devices.

RCT Entities:   Population Interventions Outcomes