Condition category
Circulatory System
Date applied
22/06/2019
Date assigned
01/07/2019
Last edited
05/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Venous thromboembolism (VTE) is a condition in which a blood clot forms most often in the deep veins of the leg, groin or arm (known as deep vein thrombosis, DVT) and travels in the circulation, lodging in the lungs (known as pulmonary embolism, PE). Together, DVT and PE are known as VTE - a dangerous, potentially deadly medical condition. VTE is a serious complication with a high incidence during and after hospitalization, and it is also an important factor in deaths before and after surgery and unexpected deaths in hospitals. In patients who undergo hip fracture surgery, it is recommended that the duration of drug prevention be at least 10 days and extendable to 11–35 days. Several studies have shown that extended prophylaxis substantially reduces the risk of VTE and recommend a longer prophylaxis duration in all patients undergoing hip fracture surgery. This study compares the use of aspirin and rivaroxaban for the prevention of blood clots following hip surgery.

Who can participate?
Patients with hip fracture who require surgery.

What does the study involve?
All patients were given enoxaparin after the operation and returned to a routine dose the next day until postoperative day five. The patients in the aspirin group received an additional 16 days of thromboprophylaxis with 100 mg of aspirin once daily. The rivaroxaban group was assigned to receive an additional 16 days of thromboprophylaxis with 10 mg of oral rivaroxaban once daily.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Chengdu Fifth People’s Hospital, Chengdu, China

When is the study starting and how long is it expected to run for?
November 2011 to March 2018

Who is funding the study?
Investigator funded

Who is the main contact?
Dr Qiang Huang
huangqiang8111@163.com

Trial website

Contact information

Type

Public

Primary contact

Dr Qiang Huang

ORCID ID

http://orcid.org/0000-0003-2559-0249

Contact details

No.33,Ma-shi street
Wenjiang District
Chengdu
Sichuan Province
Chengdu
611130
China
028-82722252
cds5120@163.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Comparison of the efficacy and safety of aspirin and rivaroxaban following enoxaparin treatment for prevention of VTE after hip fracture surgery

Acronym

CESARFETPVTEHFS

Study hypothesis

Aspirin may have equal efficiency and safety with the direct oral anticoagulant rivaroxaban for the prevention of venous thromboembolism after hip fracture surgery

Ethics approval

Approved 16/09/2011, Medical Ethics Committee of Chengdu Fifth People’s Hospital (No. 56 Wanchun East Road, Wenjiang District, Chengdu, Sichuan Province, China; 028-82783867; cdwyiec@163.com), ref: 2019075101

Study design

Interventional pseudorandomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Prevention of venous thromboembolism after hip fracture surgery

Intervention

The patients were divided into the aspirin group and rivaroxaban group according to odd or even number of the end of the registration number. All patients were given enoxaparin subcutaneous injection after the operation and returned to a routine dose the next day until postoperative day 5. The patients in the aspirin group received an additional 16 days of thromboprophylaxis with 100 mg of aspirin once daily. The rivaroxaban group was assigned to receive an additional 16 days of thromboprophylaxis with 10 mg of oral rivaroxaban once daily.

Intervention type

Drug

Phase

Not Applicable

Drug names

Aspirin, rivaroxaban

Primary outcome measure

1. Adjudicated venous thromboembolism, which was defined as deep vein thrombosis involving the inferior vena cava to popliteal vein or pulmonary embolism. Ultrasonography of the lower extremity vein is a routine examination. All patients had to be examined before and after surgery. Pulmonary embolism was confirmed by computed tomographic pulmonary angiography, when the patient's symptoms are suspected to be a pulmonary embolism.
2. The primary safety outcome was bleeding, including major or clinically relevant nonmajor bleeding, according to Anderson’s criteria. Patients were followed for 90 days regarding venous thromboembolism and bleeding complications.

Secondary outcome measures

Incidence of health issues in the 90 days following the intervention:
1. Death
2. Myocardial infarction
3. Stroke
4. Wound infection.

Overall trial start date

08/09/2011

Overall trial end date

31/03/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Hip fracture who were diagnosed by X-ray and/or computed tomography.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Aspirin grounp (n=198 patients); Rivaroxaban group (n=192 patients)

Participant exclusion criteria

1. Lower extremity DVT confirmed by preoperative ultrasonography
2. History of thromboembolic disease and undergoing anticoagulant therapy
3. Presence of hemorrhagic diseases and/or a major bleeding history
4. Severe liver or kidney diseases
5. Coagulation disorders
6. Allergy to enoxaparin, aspirin, or rivaroxaban
7. Platelet count less than 100*10^9 cells/L

Recruitment start date

12/11/2011

Recruitment end date

02/01/2018

Locations

Countries of recruitment

China

Trial participating centre

Chengdu Fifth People’s Hospital
No.33 Ma-shi street Wenjiang District Chengdu Sichuan Province
Chengdu
611130
China

Sponsor information

Organisation

Department of Orthopedic Surgery, West China Hospital, Sichuan University

Sponsor details

No. 37
Guo-xue Lane
Wuhou District
Chengdu
Sichuan Province
Chengdu
611430
China
028-85422430
shenbin_1971@163.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The intention is to publish the results of this study, in peer-reviewed journals.The results will be made available online, if permitted by journal policies.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

01/10/2019

Participant level data

Available on request

Basic results (scientific)

The incidence of VTE in the aspirin group and rivaroxaban group was 6.6% (13/198) and 5.7% (11/192), respectively, with no significant difference between the groups (P =0.465). The rate of major bleeding events occurred in 2 (1.0%) patients in the aspirin group and in 1 (0.5%) in the rivaroxaban group without a significant difference (P=0.983). During the 90-day follow-up, a pulmonary embolism developed in 1 patient (0.5%) in the aspirin group and none in the rivaroxaban group, with no significant difference between the two groups (P=0.465).

Publication list

Publication citations

Additional files

Editorial Notes

05/07/2019: Internal review. 01/07/2019: Trial's existence confirmed by Medical Ethics Committee of Chengdu Fifth People’s Hospital.