NCT03044574: IPCSUPER

Intermittent Pneumatic Compression in Surgical Patients at Extremely-high Risk for Venous Thromboembolism

Completed NA Results posted Last updated 4 February 2021

What this trial tests

NA trial testing SCD in Venous Thromboembolism in 407 participants. Completed in 31 December 2018.

Timeline

1 February 2017

Primary endpoint
30 September 2018

31 December 2018

Quick facts

Lead sponsor	Pirogov Russian National Research Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	407
Start date	1 February 2017
Primary completion	30 September 2018
Estimated completion	31 December 2018
Sites	2 locations across Russia

Drugs / interventions tested

• SCD
• GCS
• LMWH (lmwh) — full drug profile →

Conditions studied

• Venous Thromboembolism — all drugs for Venous Thromboembolism →
• Venous Thrombosis — all drugs for Venous Thrombosis →

Sponsor

Pirogov Russian National Research Medical University

Who can join

40 and older, any sex, with Venous Thromboembolism or Venous Thrombosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound Primary · time of discharge from the hospital or death, up to 45 days

Asymptomatic deep and/or superficial vein thrombosis of lower limbs detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.

Group	Value	95% CI
Experimental Group (SCD + GCS + LMWH)	1
Control Group (GCS + LMWH)	34

Number of Patients With Proximal Deep Venous Thrombosis as Detected by Duplex Ultrasound Secondary · time of discharge from the hospital or death, up to 45 days

Proximal deep vein thrombosis defined as thrombus of popliteal, femoral, iliac veins and/or inferior vena cava. Detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.

Group	Value	95% CI
Experimental Group (SCD + GCS + LMWH)	0
Control Group (GCS + LMWH)	5

Number of Patients With Isolated Calf Muscle Vein Thrombosis as Detected by Duplex Ultrasound Secondary · time of discharge from the hospital or death, up to 45 days

Isolated calf muscle vein thrombosis was defined as thrombosis of soleal, gastrocnemius or other calf muscle veins not extended into tibial, or peroneal, or popliteal veins. Detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.

Group	Value	95% CI
Experimental Group (SCD + GCS + LMWH)	1
Control Group (GCS + LMWH)	15

Number of Patients With Pulmonary Embolism Secondary · time of discharge from the hospital or death, up to 45 days

Symptomatic pulmonary embolism (PE) that occurred during the inpatient period of treatment and confirmed by computed tomography pulmonary angiogram (CTPA) or single-photon emission computed tomography with computed tomography (SPECT/CT) or autopsy

Group	Value	95% CI
Experimental Group (SCD + GCS + LMWH)	0
Control Group (GCS + LMWH)	5

Number of Patients Died From Any Reason Secondary · time of discharge from the hospital or death, up to 45 days

Inpatient postoperative mortality: number of patients died from any reason during the inpatient period of treatment

Group	Value	95% CI
Experimental Group (SCD + GCS + LMWH)	6
Control Group (GCS + LMWH)	10

Number of Patients With Leg Skin Injury Secondary · time of discharge from the hospital or death, up to 45 days

Leg skin injury defined as any skin hyperemia, maceration, laceration, bubbles, erosion or ulceration in the zone of application for GCS and SCD on the lower limbs revealed by clinical inspection of the skin and soft tissues until discharge

Group	Value	95% CI
Experimental Group (SCD + GCS + LMWH)	25
Control Group (GCS + LMWH)	15

Number of Patients With Symptomatic and Asymptomatic VTE Events at 30 Days After Surgery Secondary · 30 days

Taking into account all VTE events: asymptomatic revealed by duplex ultrasound, symptomatic confirmed by duplex ultrasound, CTPA, SPECT/CT, autopsy in patients discharged from the hospital and still receiving inpatients care at 30 days after surgery.

Group	Value	95% CI
Experimental Group (SCD + GCS + LMWH)	1
Control Group (GCS + LMWH)	35

Number of Patients Who Died From VTE at 30 Days After Surgery Secondary · 30 days

VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy

Group	Value	95% CI
Experimental Group (SCD + GCS + LMWH)	0
Control Group (GCS + LMWH)	2

Number of Patients With Symptomatic and Asymptomatic VTE Events at 180 Days After Surgery Secondary · 180 days

Taking into account all symptomatic and asymptomatic VTE events confirmed by duplex ultrasound, CTPA, SPECT/CT, autopsy or other appropriate methods of diagnosis that occurred during the inpatient period of treatment and outpatient period of observation

Group	Value	95% CI
Experimental Group (SCD + GCS + LMWH)	1
Control Group (GCS + LMWH)	35

Number of Patients Who Died From VTE at 180 Days After Surgery Secondary · 180 days

VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy

Group	Value	95% CI
Experimental Group (SCD + GCS + LMWH)	0
Control Group (GCS + LMWH)	3

Duration of Inpatient Period of Treatment Secondary · time of discharge from the hospital or death, up to 45 days

The inpatient period of treatment suggests time from surgical intervention to discharge from the hospital or death.

Group	Value	95% CI
Experimental Group (SCD + GCS + LMWH)	10	8 – 12
Control Group (GCS + LMWH)	10	8 – 13

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days after surgery for most of the adverse events except all-cause mortality that reported over 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental Group (SCD + GCS + LMWH)

Serious: 5/204 (2%)

Deaths: 11/204

Control Group (GCS + LMWH)

Serious: 4/203 (2%)

Deaths: 18/203

Serious adverse events (1 terms)

Reaction	System	Experimental Group (SCD + …	Control Group (GCS + LMWH)
Major bleeding	Blood and lymphatic system disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Experimental Group (SCD + …	Control Group (GCS + LMWH)
Skin hyperemia on lower limbs	Injury, poisoning and procedural complications	—	—
Clinical relevant non-major bleeding	Blood and lymphatic system disorders	—	—
Skin necrosis on lower limbs	Injury, poisoning and procedural complications	—	—
Skin blisters on lower limbs	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Major bleeding.

Data from ClinicalTrials.gov NCT03044574 adverse events section.

Sponsor's own description

The aim of the study is to evaluate efficacy and safety of venous thromboembolism prophylaxis by the combination of graduated compression stockings (GCS), standard doses of low-molecular-weight heparins (LMWH) and sequential compression device (SCD) in the mixed group of surgical patients at high and extremely high risk for venous thromboembolism.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.