Study to Evaluate the Role of Systemic Postoperative Anticoagulation Therapy in Patients Undergoing Medium-Sized Peripheral Artery Repair Following Trauma: a Randomized Controlled Trial

The aim of this study is to compare outcomes of patients with and without use of systemic post-operative anti-coagulation (SPAC) having undergone end to end medium-sized arterial repair following trauma. A prospective, single-blinded, pilot randomized control trial was conducted at a level 1 trauma center from April 2019 through August 2020. Patients between 14 and 65 years having medium size vessel injury and undergoing end to end arterial repair were included. Patients were randomized into two groups—SPAC and no SPAC. Primary outcome measure was vessel patency measured clinically and/or by Doppler at 48 h and at the time of discharge. Secondary outcome measures included post-operative bleeding, re-exploration, ongoing blood product transfusion, limb salvage, duration of ICU stay, and hospital stay. A total of 32 patients were randomized. There was no difference in vessel patency at 48 h. (93.7% vs. 93.7%, p value 0.572) or at discharge (93.7% vs. 87.5%, p value 0.654). Incidence of post-operative hemorrhage (5 patients vs. 0, p value 0.030), need for additional vascular procedures (37.5% vs. 18.75, p value 0.030), need for further post-operative transfusions (50% vs. 12.5%, p value 0.040), and additional operative procedures (30 vs. 18, p value 0.024) were more in the SPAC group. There was no difference in limb salvage rates (93.7% vs. 87.5%, p value 0.513), rates of fasciotomy (68% vs. 56.3%, p value 0.412), hospital stay (mean 20.12 vs. 16.28 days, p value 0.663), and ICU stay (mean 0.81 vs. 2.7 days, p value 0.358). SPAC does not seem to improve post-operative vessel patency following end to end arterial repair of injured medium-sized vessels. An increase in adverse events following use of SPAC was noted. An adequately powered randomized trial is needed to conclusively bridge the lacunae on the use of anticoagulation in these groups of patients. Trial Registry: ctri.nic.in/clinical trials/login.php, number REF/2019/04/018649 dated 18/04/2019