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A clinical trial study to determine the role of chemical thrombo-prophylaxis in patients undergoing arthroscopic anterior cruciate ligament reconstructive surgery

A prospective randomized controlled study to determine the role of chemical thrombo-prophylaxis in patients undergoing arthroscopic anterior cruciate ligament reconstructive surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034419
Enrollment
240
Registered
2021-06-28
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: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: Enoxaparin and Rivaroxaban: Injection Enoxaparin 40mg first dose 8 hours after surgery and second dose 24 hours after the first dose followed by tablet Rivaroxaban 10mg once daily for 1

Sponsors

Dinshaw Pardiwala
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients undergoing arthroscopic ACL reconstruction (with or without associated meniscus or chondral surgery) 2. Age group 16 to 60 year 3 Gender Male and female patients will be included 4 Patients who would voluntarily agree to sign informed consent form 5. Patients who would be available to perform the postoperative color Doppler evalua-tion at KDAH.

Exclusion criteria

Exclusion criteria: 1 Patients undergoing arthroscopic ACL reconstruction associated with other ligament re-constructive surgery that is arthroscopic bicruciate reconstructions and multiple ligament reconstructions 2 Age group : 60 years 3 Patients diagnosed with acute or chronic DVT on preoperative venous color Doppler 4 Patients having a high risk of DVT which would under normal circumstances warrant mandatory chemical thromboprophylaxis including previous history of DVT or PE, his-tory of recent malignancy (within the past 12 months), pregnancy, or patients on oral contraceptives. 5 History of thrombophilic conditions 6 A patient having more than 3 risk factors for developing DVT would be excluded. These include : smoking, nicotine abuse, hormonal replacement therapy, antipsychotic treatment, varicose vein, family history of thrombosis, ongoing treatment with steroids, anticoagulant or antiplatelet agents, history of gastrointestinal bleeding in the past 2 weeks

Design outcomes

Primary

MeasureTime frame
The number of patients in each group who developed Deep Vein Thrombosis or Pulmonary Embolism.Timepoint: At 5 to 9 days and after 4 to 6 week post surgery

Secondary

MeasureTime frame
Adverse events in group A (treatment group) secondary to chemical thromboprophylaxis.Timepoint: At 5 to 9 days and after 4 to 6 week post surgery

Countries

India

Contacts

Public ContactDINSHAW PARDIWALA

Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute

pardiwala@outlook.com9820869267

Outcome results

None listed

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