Trial Outcomes & Findings for Intermittent Pneumatic Compression in Surgical Patients at Extremely-high Risk for Venous Thromboembolism (NCT NCT03044574)
NCT ID: NCT03044574
Last Updated: 2021-02-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
407 participants
Primary outcome timeframe
time of discharge from the hospital or death, up to 45 days
Results posted on
2021-02-04
Participant Flow
The total amount of 812 patients were screened during the enrollment period, 405 of them were excluded: Caprini score of \<11 (n=304); a various regimen of anticoagulation (n=48); venous thrombosis at the baseline (n=31); declined participation (n=18); implanted inferior vena cava filter (n=4).
Participant milestones
| Measure |
Experimental Group (SCD + GCS + LMWH)
Sequential Compression Device (SCD): Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
Graduated Compression Stockings (GCS): Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
Low-Molecular-Weight-Heparin (LMWH): LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Overall Study
STARTED
|
204
|
203
|
|
Overall Study
Inpatient Period
|
204
|
203
|
|
Overall Study
30 Days After Surgery
|
193
|
194
|
|
Overall Study
180 Days After Surgery
|
167
|
158
|
|
Overall Study
COMPLETED
|
167
|
158
|
|
Overall Study
NOT COMPLETED
|
37
|
45
|
Reasons for withdrawal
| Measure |
Experimental Group (SCD + GCS + LMWH)
Sequential Compression Device (SCD): Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
Graduated Compression Stockings (GCS): Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
Low-Molecular-Weight-Heparin (LMWH): LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
37
|
45
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=204 Participants
Sequential Compression Device (SCD): Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with a 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in the surgery department - all time of bed rest. SCD used until discharge.
Graduated Compression Stockings (GCS): Thigh-length graduated compression stockings with a pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
Low-Molecular-Weight Heparin: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=203 Participants
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Total
n=407 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 9.6 • n=204 Participants
|
68.8 years
STANDARD_DEVIATION 10.0 • n=203 Participants
|
68.8 years
STANDARD_DEVIATION 9.8 • n=407 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=204 Participants
|
118 Participants
n=203 Participants
|
247 Participants
n=407 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=204 Participants
|
85 Participants
n=203 Participants
|
160 Participants
n=407 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
204 Participants
n=204 Participants
|
203 Participants
n=203 Participants
|
407 Participants
n=407 Participants
|
|
Surgical profile
Addominal surgery
|
131 Participants
n=204 Participants
|
147 Participants
n=203 Participants
|
278 Participants
n=407 Participants
|
|
Surgical profile
Non-abdominal surgery
|
73 Participants
n=204 Participants
|
56 Participants
n=203 Participants
|
129 Participants
n=407 Participants
|
|
Malignancy
|
171 Participants
n=204 Participants
|
165 Participants
n=203 Participants
|
336 Participants
n=407 Participants
|
|
Caprini score
|
11.5 units on a scale
STANDARD_DEVIATION 1.8 • n=204 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 1.9 • n=203 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 1.9 • n=407 Participants
|
|
Number of patients with Caprini score of 11 and higher
|
145 Participants
n=204 Participants
|
140 Participants
n=203 Participants
|
285 Participants
n=407 Participants
|
PRIMARY outcome
Timeframe: time of discharge from the hospital or death, up to 45 daysAsymptomatic 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.
Outcome measures
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=204 Participants
SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=203 Participants
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound
|
1 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: time of discharge from the hospital or death, up to 45 daysProximal 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.
Outcome measures
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=204 Participants
SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=203 Participants
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Number of Patients With Proximal Deep Venous Thrombosis as Detected by Duplex Ultrasound
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: time of discharge from the hospital or death, up to 45 daysIsolated 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.
Outcome measures
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=204 Participants
SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=203 Participants
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Number of Patients With Isolated Calf Muscle Vein Thrombosis as Detected by Duplex Ultrasound
|
1 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: time of discharge from the hospital or death, up to 45 daysSymptomatic 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
Outcome measures
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=204 Participants
SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=203 Participants
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Number of Patients With Pulmonary Embolism
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: time of discharge from the hospital or death, up to 45 daysInpatient postoperative mortality: number of patients died from any reason during the inpatient period of treatment
Outcome measures
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=204 Participants
SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=203 Participants
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Number of Patients Died From Any Reason
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: time of discharge from the hospital or death, up to 45 daysLeg 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
Outcome measures
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=204 Participants
SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=203 Participants
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Number of Patients With Leg Skin Injury
|
25 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 30 daysTaking 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.
Outcome measures
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=193 Participants
SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=194 Participants
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Number of Patients With Symptomatic and Asymptomatic VTE Events at 30 Days After Surgery
|
1 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 30 daysVTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy
Outcome measures
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=193 Participants
SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=194 Participants
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Number of Patients Who Died From VTE at 30 Days After Surgery
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 180 daysTaking 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
Outcome measures
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=167 Participants
SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=158 Participants
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Number of Patients With Symptomatic and Asymptomatic VTE Events at 180 Days After Surgery
|
1 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 180 daysVTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy
Outcome measures
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=167 Participants
SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=158 Participants
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Number of Patients Who Died From VTE at 180 Days After Surgery
|
0 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: time of discharge from the hospital or death, up to 45 daysThe inpatient period of treatment suggests time from surgical intervention to discharge from the hospital or death.
Outcome measures
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=204 Participants
SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=203 Participants
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Duration of Inpatient Period of Treatment
|
10 days
Interval 8.0 to 12.0
|
10 days
Interval 8.0 to 13.0
|
Adverse Events
Experimental Group (SCD + GCS + LMWH)
Serious events: 5 serious events
Other events: 27 other events
Deaths: 11 deaths
Control Group (GCS + LMWH)
Serious events: 4 serious events
Other events: 22 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=204 participants at risk
SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=203 participants at risk
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Blood and lymphatic system disorders
Major bleeding
|
2.5%
5/204 • Number of events 5 • 30 days after surgery for most of the adverse events except all-cause mortality that reported over 6 months
|
2.0%
4/203 • Number of events 4 • 30 days after surgery for most of the adverse events except all-cause mortality that reported over 6 months
|
Other adverse events
| Measure |
Experimental Group (SCD + GCS + LMWH)
n=204 participants at risk
SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
Control Group (GCS + LMWH)
n=203 participants at risk
GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Skin hyperemia on lower limbs
|
8.8%
18/204 • Number of events 18 • 30 days after surgery for most of the adverse events except all-cause mortality that reported over 6 months
|
6.4%
13/203 • Number of events 13 • 30 days after surgery for most of the adverse events except all-cause mortality that reported over 6 months
|
|
Injury, poisoning and procedural complications
Skin blisters on lower limbs
|
1.5%
3/204 • Number of events 3 • 30 days after surgery for most of the adverse events except all-cause mortality that reported over 6 months
|
0.49%
1/203 • Number of events 1 • 30 days after surgery for most of the adverse events except all-cause mortality that reported over 6 months
|
|
Injury, poisoning and procedural complications
Skin necrosis on lower limbs
|
2.0%
4/204 • Number of events 4 • 30 days after surgery for most of the adverse events except all-cause mortality that reported over 6 months
|
0.49%
1/203 • Number of events 1 • 30 days after surgery for most of the adverse events except all-cause mortality that reported over 6 months
|
|
Blood and lymphatic system disorders
Clinical relevant non-major bleeding
|
0.98%
2/204 • Number of events 2 • 30 days after surgery for most of the adverse events except all-cause mortality that reported over 6 months
|
3.4%
7/203 • Number of events 7 • 30 days after surgery for most of the adverse events except all-cause mortality that reported over 6 months
|
Additional Information
Dr. Kirill Lobastov, Associated professor at the Department of General Surgery and Radiology
Pirogov Russian National Researching Medical University
Phone: +7-985-211-63-31
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place