• CLOTS (Clots in Legs Or sTockings after Stroke) Trial Collaboration.
• University of Edinburgh, Western General Hospital, Edinburgh, United Kingdom.
• Ann. Intern. Med. 2010 Nov 2; 153 (9): 553-62.

BackgroundGraduated compression stockings are widely used for deep venous thrombosis (DVT) prophylaxis. Although below-knee stockings are used more often than thigh-length stockings, no reliable evidence indicates that they are as effective as thigh-length stockings.ObjectiveTo compare the effectiveness of thigh-length stockings with that of below-knee stockings for preventing proximal DVT in immobile, hospitalized patients with stroke.DesignParallel-group trial with centralized randomization (minimization within centers) to ensure allocation concealment. The ultrasonographers who looked for DVT were blinded, but the patients and caregivers were not. (Controlled-trials.com registration number: ISRCTN28163533)Setting112 hospitals in 9 countries.Patients3114 immobile patients hospitalized with acute stroke between January 2002 and May 2009.Intervention1552 patients received thigh-length stockings and 1562 patients received below-knee stockings to wear while they were in the hospital.MeasurementsUltrasonographers performed compression duplex ultrasonography in 1406 patients (96% of survivors) in each treatment group between 7 and 10 days after enrollment. They performed a second scan in 643 patients in the thigh-length stockings group and 639 in the below-knee stockings group at about 25 to 30 days. The primary outcome was symptomatic or asymptomatic DVT in the popliteal or femoral veins, detected on either scan.ResultsPatients were retained in their assigned group for all analyses. The primary outcome occurred in 98 patients (6.3%) who received thigh-length stockings and 138 (8.8%) who received below-knee stockings (absolute difference, 2.5 percentage points [95% CI, 0.7 to 4.4 percentage points]; P = 0.008), an odds reduction of 31% (CI, 9% to 47%). Seventy-five percent of patients in both groups wore the stockings for 30 days or until they were discharged, died, or regained mobility. Skin breaks occurred in 61 patients who received thigh-length stockings (3.9%) and 45 (2.9%) who received below-knee stockings.LimitationBlinding was incomplete, 2 scans were not obtained for all enrolled patients, and the trial was stopped before the target accrual was reached.ConclusionProximal DVT occurs more often in patients with stroke who wear below-knee stockings than in those who wear thigh-length stockings.Primary Funding SourceMedical Research Council of the United Kingdom, Chief Scientist Office of the Scottish Government, and Chest Heart and Stroke Scotland.

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