NCT03821597

Brief Summary

This study investigates a possible fibrinolytic effect of sequential compression devices (SCDs). These devices have been used for decades to reduce risk of deep venous thrombosis (DVT). However, a randomized study in plastic surgery outpatients has not been done. This study is undertaken to remedy that deficiency in our knowledge base.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

January 27, 2019

Last Update Submit

January 29, 2019

Conditions

Blood Coagulation Disorder

Keywords

Fibrinolysis, sequential compression devices

Outcome Measures

Primary Outcomes (1)

  • Change in plasma levels of tissue plasminogen activator and plasminogen activator inhibitor-1

    Laboratory testing of serum levels

    1-2 months

Study Arms (2)

Sequential compression devices

EXPERIMENTAL

Sequential compression devices (SCDs) are applied during surgery.

Procedure: Sequential compression devices (SCDs)

No sequential compression devices

ACTIVE COMPARATOR

No sequential compression devices are applied.

Procedure: No sequential compression.

Interventions

Sequential compression devices (SCDs)PROCEDURE

Application of sequential compression devices in surgery.

Sequential compression devices
No sequential compression.PROCEDURE

No sequential compression devices are applied.

No sequential compression devices

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All healthy patients aged 18 or more.

You may not qualify if:

  • These conditions include suspected active or untreated DVT, pulmonary edema, congestive heart failure, thrombophlebitis or an active infection, vein ligation, gangrene, dermatitis, open wounds, a recent skin graft, massive edema or extreme deformity of the leg, neuropathy, legs that are insensitive to pain, or when increased venous or lymphatic return is undesirable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swanson Center

Leawood, Kansas, 66211, United States

Location

Related Publications (4)

  • Comerota AJ, Chouhan V, Harada RN, Sun L, Hosking J, Veermansunemi R, Comerota AJ Jr, Schlappy D, Rao AK. The fibrinolytic effects of intermittent pneumatic compression: mechanism of enhanced fibrinolysis. Ann Surg. 1997 Sep;226(3):306-13; discussion 313-4. doi: 10.1097/00000658-199709000-00010.

    PMID: 9339937BACKGROUND

  • Swanson E. Do Sequential Compression Devices Really Reduce the Risk of Venous Thromboembolism in Plastic Surgery Patients? Plast Reconstr Surg. 2015 Oct;136(4):577e-578e. doi: 10.1097/PRS.0000000000001587. No abstract available.

    PMID: 26114974BACKGROUND

  • Murphy RX Jr, Alderman A, Gutowski K, Kerrigan C, Rosolowski K, Schechter L, Schmitz D, Wilkins E. Evidence-based practices for thromboembolism prevention: summary of the ASPS Venous Thromboembolism Task Force Report. Plast Reconstr Surg. 2012 Jul;130(1):168e-175e. doi: 10.1097/PRS.0b013e318254b4ee.

    PMID: 22743901BACKGROUND

  • Swanson E. Ultrasound screening for deep venous thrombosis detection: a prospective evaluation of 200 plastic surgery outpatients. Plast Reconstr Surg Glob Open. 2015 Apr 7;3(3):e332. doi: 10.1097/GOX.0000000000000311. eCollection 2015 Mar.

    PMID: 25878943BACKGROUND

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Eric Swanson, M.D.

    Swanson Cener

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective, randomized, controlled study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2019

First Posted

January 30, 2019

Study Start

November 1, 2018

Primary Completion

December 31, 2018

Study Completion

January 27, 2019

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)