Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty

Deep Vein Thrombosis Clinical Trial

Official title:

Phase II Study of Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446887
• Other study ID #: NJDVTS
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 28, 2011
• Last updated: October 8, 2011
• Start date: January 2007
• Est. completion date: February 2011

Study information

• Verified date: October 2011
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Deep vein thrombosis (DVT) remains a life-threatening complication of arthroplasty. It remains controversial for anticoagulation strategies after total hip arthroplasty (THA). A randomized double-blind study was conducted to determine whether prophylactic anticoagulation was efficient reduce DVT after THA. subjects who underwent uncemented THA were assigned to prophylactic anticoagulation group or non- prophylactic anticoagulation group. Patients were followed up 3 months later after surgery. DVT was tested by contrast venography. Investigator also used logistic regression analysis with variable selection for obtaining the prediction model of DVT. DVT after THA was affected by personal (age) and clinical factors (mechanical compression, duration of surgery). THA with short duration of surgery did not require prophylactic anticoagulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 90 Years

Eligibility

Inclusion Criteria:

• Primary total hip arthroplasty

Exclusion Criteria:

• Revision hip replacement, total knee replacement, revision knee replacement, semi-hip replacement and cemented THR were excluded.

• Coagulation related disease and cancer were excluded either.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• prophylactic anticoagulation
prophylactic anticoagulation by rivaroxaban

Locations

Country	Name	City	State
China	The Center of Diagnosis and Treatment for Joint Disease, Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
JIANG Qing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause DVT	deep-vein thrombosis nonfatal pulmonary embolism, or death	7 days	Yes
Secondary	Major DVT	major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism)	7 days	Yes