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Intermittent Pneumatic compression, Routine care

Phase 3

Stroke | Unknown | Neurology |Medtronic plc.|Last Updated: Jun 23, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment2,876

FDA Designations

No designations recorded

Clinical trial landscape

Intermittent Pneumatic compression, Routine care · 1 trial · 1 indication

Phase 3 1
NCT00789542A RCT to Establish the Effectiveness of Intermittent Pneumatic Compression to Prevent Post Stroke DVTStroke
COMPLETED2,876 Analytics
PHASE3COMPLETED
A RCT to Establish the Effectiveness of Intermittent Pneumatic Compression to Prevent Post Stroke DVT
StrokeUnlock trial analytics

Study Endpoints

Primary Endpoints

Presence of definite/probable symptomatic/asymptomatic DVT in the popliteal or femoral veins (PFV) or any symptomatic DVT in the PFV within 30 days of randomisation.
30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Intermittent Pneumatic CompressionEXPERIMENTALSCD Express device applied with thigh length sleeves for up to 30 days
Routine careOTHERRoutine care which might include: early mobilisation, adequate hydration, aspirin if ischaemic stroke and graduated compression stockings according to local protocols.

Interventions

NameTypeDescription
Intermittent Pneumatic compressionDEVICEThigh length sleeves applied to both legs from randomization to Day 30 (Day and night) whilst sitting and lying
Routine careOTHERRoutine care which might include: early mobilization, adequate hydration, aspirin if ischemic stroke and graduated compression stockings according to local protocols.
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Any patient admitted to hospital within 3 days of a clinical stroke fulfilling the WHO criteria. and • Who is not able to get up from a chair/ out of bed and walk to the toilet without the help of another person Patients can be randomised from Day 0 (day of admission) to Da...

Countries:United Kingdom
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Frequently asked questions about Intermittent Pneumatic compression, Routine care

What is Intermittent Pneumatic Compression used for in stroke?

Intermittent Pneumatic Compression is being studied for use in stroke patients to prevent post-stroke deep vein thrombosis (DVT). It is an investigational treatment evaluated in a Phase 3 clinical trial. The therapy is not yet approved and remains in clinical development.

Who makes Intermittent Pneumatic Compression?

Medtronic plc (NYSE: MDT) is developing Intermittent Pneumatic Compression. The company is conducting a Phase 3 clinical trial to evaluate its effectiveness in preventing deep vein thrombosis in stroke patients.

What phase is Intermittent Pneumatic Compression in?

Intermittent Pneumatic Compression is in Phase 3 clinical development. It is an investigational therapy being studied for the prevention of deep vein thrombosis in stroke patients. It is not yet approved by regulatory authorities.

What clinical trials is Intermittent Pneumatic Compression in?

Intermittent Pneumatic Compression is studied in one completed Phase 3 trial, NCT00789542, titled 'A RCT to Establish the Effectiveness of Intermittent Pneumatic Compression to Prevent Post Stroke DVT.' The trial enrolled 2,876 participants in the United Kingdom and was completed.

Is Intermittent Pneumatic Compression the same as routine care?

Intermittent Pneumatic Compression is distinct from routine care. In the clinical trial, it was compared against routine care as a controlled intervention. The trial was randomized but not double-blinded, and it enrolled 2,876 stroke patients.