Clots in Legs Or sTockings after Stroke - CLOTS Trial 1

Jun 03, 2009
Font Size
A
A
A
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Medical Research Council, Chief Scientist Office of Scottish Government, Chest Heart and Stroke Scotland, Tyco Healthcare, and UK Stroke Research Network
Date Published:
01/01/2009
Date Updated:
06/03/2009
Original Posted Date:
06/03/2009
References

Description:

The goal of the trial was to evaluate the use of thigh-length graduated compression stockings compared with routine care among patients with a recent stroke (<1 week).

Hypothesis:

Graduated compression stockings will be more effective in preventing pulmonary embolus and deep vein thrombosis.

Study Design

  • Randomized
  • Blinded
  • Parallel

Patients Enrolled: 2,518
Mean Follow Up: 30 days
Mean Patient Age: 76 years
Female: 51%

Patient Populations:

  • Patients who were immobile due to recent stroke (<1 week)

Exclusions:

  • Subarachnoid hemorrhage
  • Peripheral arterial disease
  • Diabetic or sensory neuropathy

Primary Endpoints:

  • Symptomatic or asymptomatic deep vein thrombosis in the popliteal or femoral veins within 30 days

Secondary Endpoints:

  • Death
  • Any deep vein thrombosis, including calf
  • Symptomatic deep vein thrombosis
  • Pulmonary embolus
  • Skin trauma from compression stockings
  • Compliance

Drug/Procedures Used:

Patients with recent stroke (<1 week) and who were immobile, were randomized to graduated compression stockings (n = 1,256) versus routine care (n = 1,262).

Principal Findings:

Overall, 2,518 patients were randomized. The mean age was 76 years, 51% were women, 84% of patients suffered an ischemic stroke, and 43% were able to lift both legs off the bed.

The primary outcome, symptomatic or asymptomatic deep vein thrombosis, occurred in 10.0% of the graduated compression stocking group versus 10.5% of the routine care group. Skin trauma was common in the graduate compression stocking group (5% vs. 1%; p < 0.05).

Death at 30 days was 9.7% versus 8.7%, any deep vein thrombosis was 16.3% versus 17.7%, pulmonary embolus was 1.0% versus 1.6%, and lower extremity ischemia/amputation was 0.6% versus 0.2%.

Interpretation:

Among immobile patients who recently had a stroke, the use of thigh-length graduated compression stockings was not superior to routine care. These stockings did not reduce the incidence of symptomatic or asymptomatic deep vein thrombosis, although they did result in more skin trauma (for example; breaks, ulcers, blisters, or necrosis) and a nonsignificant increase in lower extremity ischemia/amputation.

Severe stroke significantly increases the risk of deep vein thrombosis and pulmonary embolus; however, anticoagulation is relatively contraindicated due to concern of converting to a hemorrhagic stroke. Therefore, most national guidelines recommended the use of compression stockings, although without convincing data to support this approach. This research will likely result in a softening of the recommendation for graduated compression stockings among stroke patients.

References:

The CLOTS Trials Collaboration. Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): a multicentre, randomised controlled trial. Lancet 2009;May 26:[Epub ahead of print].

Keywords: Stroke, Thigh, Ulcer, Stockings, Compression, Cerebrovascular Disorders, Ischemia, Pulmonary Embolism, Venous Thrombosis, Leg, Blister


< Back to Listings