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How safe and effective is drugs like enoxaparin and apixaban is for preventing clot formation in your blood vessel after you undergo total hip or total knee replacement surgeries?

SAFETY AND EFFICACY OF APIXABAN AND ENOXAPARIN IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY AND TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE OBSERVATIONAL STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/11/016428
Enrollment
249
Registered
2018-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M164- Bilateral post-traumatic osteoarthritis of hip Health Condition 2: M160- Bilateral primary osteoarthritis of hip Health Condition 3: M170- Bilateral primary osteoarthritis of knee Health Condition 4: M169- Osteoarthritis of hip, unspecified Health Condition 5: M179- Osteoarthritis of knee, unspecified Health Condition 6: M174- Other bilateral secondary osteoarthritis of knee Health Condition 7: M175- Other unilateral secondary osteoarthritis of knee Health Condition 8:

Interventions

None listed

Sponsors

AIIMS JODHPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Signed written informed consent 1) Subjects giving informed consent. Target population 2) Subjects undergoing either elective unilateral or same-day bilateral total knee arthroplasty and total hip arthroplasty. 3) Subject willing to undergo bilateral Doppler studies.

Exclusion criteria

Exclusion criteria: 1.Hereditary (first degree) or acquired bleeding or coagulation disorder. 2.Known or suspected history of heparin-induced thrombocytopenia. 3.Need for ongoing treatment with a parenteral or oral anticoagulant (eg, Subjects with mechanical valves, warfarin-eligible atrial fibrillation). 4.Known coagulopathy. 5.Active bleeding or at high risk for bleeding. 6.Active hepatobiliary disease. 7.Any condition, in the opinion of the investigator, for which surgery or administration of an anticoagulant was contraindicated. 8.Hypersensitivity to unfractionated heparin, low molecular weight heparin, porcine products, or iodinated contrast medium. 9.Pre-operative Deep Vein Thrombosis Detected in Doppler USG and patients with previous known / documented history of thrombogenic events like DVT and pulmonary embolism

Design outcomes

Primary

MeasureTime frame
Treatment period: 1.Symptomatic DVT 2.Asymptomatic DVT 3.Pulmonary embolism 4.Any other Follow-up period (3 week for TKA and 6 weeks for THA) 1.Symptomatic DVT 2.Asymptomatic DVT 3.Pulmonary embolism 4.Any other Timepoint: 2 time points: Treatment period (Hospital stay period) Follow-up period (3 week for TKA and 6 weeks for THA)

Secondary

MeasureTime frame
Major bleeding events Bleeding at surgical site Adjuncted clinically relevant non-major bleeding events Minor bleeding events Wound complications Timepoint: 3 week for TKA and 6 weeks for THA

Countries

India

Contacts

Public ContactKISHOR KUNAL

AIIMS, JODHPUR

dvsh_jalan@yahoo.com8003996897

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026