ENhanced recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis after primary Hip Arthroplasty

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

26 Nov 2024 → ongoing

Decision date (initial)

2024-08-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Deutsche Forschungsgemeinschaft

External identifiers

EU CT number

2023-507490-18-00

ClinicalTrials.gov

NCT06611319

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To investigate whether, in patients undergoing elective THA following a fast-track
protocol that includes modern surgical techniques as well as early mobilization
and discharge of patients from the hospital after surgery, reduced duration (10
days) of postoperative thromboprophylaxis with a direct (non-vitamin K
antagonist) oral anticoagulant (DOAC) is non-inferior to the standard duration (35
days) of thromboprophylaxis with regard to prevention of acute symptomatic
venous thromboembolism (VTE), defined as symptomatic proximal deep vein
thrombosis (DVT) or symptomatic or fatal pulmonary embolism (PE).

Secondary objectives 11

1. Death from any cause
2. Isolated symptomatic distal DVT
3. Myocardial infarction or stroke
4. Need for readmission to the hospital
5. Length of hospital stay
6. Patient mobility
7. Changes in patient-reported hip joint-specific disability following surgery
8. Generic quality of life
9. Postoperative healthcare resource utilization
10. Major or clinically relevant non-major bleeding
11. Serious adverse events (SAEs)

Conditions and MedDRA coding

Patients undergoing elective unilateral primary hip arthroplasty, who fulfil the criteria for a fast-track protocol including early mobilization and discharge from the hospital after surgery.

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Written informed consent
2. Age between 18 and 85 years
3. Scheduled to undergo elective unilateral primary THA and eligible for perioperative management as per fast-track protocol including early mobilization and discharge from the hospital after surgery
4. Baseline Timed Up and Go (TUG) test scoring < 20 seconds, corresponding to a good mobility status before surgery
5. Capability to understand and comply with the protocol requirements (e.g., sufficient knowledge of German language to answer the questionnaires, ability to swallow intact capsules)
6. Negative serum pregnancy test and highly effective method of contraception for the duration of study treatment

Exclusion criteria 18

1. Previous DVT or PE
2. Hip or lower limb fracture in the previous three months
3. Major surgical procedure within the previous three months
4. Active cancer defined as metastatic cancer or cancer requiring chemotherapy or radiation therapy within the past six months
5. Active peptic ulcer disease or gastritis, or gastrointestinal bleeding within the past three months
6. Obesity with body mass index (BMI) > 40 kg/m² body surface area
7. Severe renal impairment defined as estimated glomerular filtration rate < 30ml/min
8. Severe hepatic impairment defined as Child Pugh Class B or C
9. Uncontrolled intercurrent illness (i.e., active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, serious gastrointestinal conditions [e.g., diarrhea, malabsorption], psychiatric illness)
10. Active or recent major bleeding at any site, or presence of any major risk factor, which, in the judgment of the investigator, may significantly increase the bleeding risk during postoperative anticoagulation treatment
11. Any medical condition representing a contraindication to discharge within 6 days after surgery
12. Expected requirement for major surgery within a 90-day period post THA
13. Need for long-term anticoagulation (e.g., atrial fibrillation, previous VTE)
14. Need for chronic antiplatelet therapy except for acetylsalicylic acid (ASA) at a dose f100 mg daily or clopidogrel 75 mg daily
15. Previous participation in this trial
16. Life expectancy < 6 months
17. Participation in another interventional clinical trial at inclusion or within the last 30 days prior to inclusion, except during the observational follow-up period of that other trial
18. History of hypersensitivity to the investigational medicinal product (IMP) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the IMP.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Participation in another interventional clinical trial at inclusion or within the last 30 days prior to inclusion, except during the observational follow-up period of that other trial

Secondary endpoints 10

1. Death from any cause
2. isolated symptomatic distal DVT
3. myocardial infarction or stroke
4. need for readmission to the hospital and length of hospital stay;
5. serious adverse events (SAEs)
6. patient mobility
7. changes in patientreported hip joint-specific disability following surgery
8. generic quality of life
9. postoperative healthcare resource utilization within the first 35 days after surgery
10. Overt major or clinically relevant non-major bleeding

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts

Sponsor organisation

Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts

Address

Langenbeckstrasse 1, Oberstadt Oberstadt

City

Mainz

Postcode

55131

Country

Germany

Scientific contact point

Organisation

Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts

Contact name

Sponsor contact point clinical trials

Public contact point

Organisation

Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts

Contact name

Sponsor contact point clinical trials

Locations

2 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 30 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications