We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 469 for:    aspirin AND prevention

Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01696760
Recruitment Status : Completed
First Posted : October 1, 2012
Results First Posted : July 4, 2014
Last Update Posted : July 4, 2014
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Bone Metastases
Musculoskeletal Cancer
Soft Tissue Sarcoma
Thromboembolism
Interventions: Drug: acetylsalicylic acid
Drug: enoxaparin
Device: PCD

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Acetylsalicylic Acid and PCD)

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

acetylsalicylic acid: 325 mg twice a day

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Arm II (Enoxaparin and PCD)

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

enoxaparin: 40 mg once daily

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.


Participant Flow:   Overall Study
    Arm I (Acetylsalicylic Acid and PCD)   Arm II (Enoxaparin and PCD)
STARTED   9   3 
COMPLETED   9   3 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I (Acetylsalicylic Acid and PCD)

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

acetylsalicylic acid: 325 mg twice a day

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Arm II (Enoxaparin and PCD)

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

enoxaparin: 40 mg once daily

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Total Total of all reporting groups

Baseline Measures
   Arm I (Acetylsalicylic Acid and PCD)   Arm II (Enoxaparin and PCD)   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   3   12 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   8   3   11 
>=65 years   1   0   1 
Gender 
[Units: Participants]
     
Female   3   2   5 
Male   6   1   7 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   1   0   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   1   1   2 
More than one race   0   1   1 
Unknown or Not Reported   7   1   8 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   0   0 
Not Hispanic or Latino   2   2   4 
Unknown or Not Reported   7   1   8 
Region of Enrollment 
[Units: Participants]
     
United States   9   3   12 


  Outcome Measures

1.  Primary:   DVT Incident Rate   [ Time Frame: Up to 3 months ]

2.  Secondary:   Pulmonary Embolism Rate   [ Time Frame: Up to 3 months ]

3.  Secondary:   Development of Other Complications (Including Bleeding Complications)   [ Time Frame: Up to 3 months ]

4.  Secondary:   Readmission Rate to Hopsital   [ Time Frame: Up to 3 months ]

5.  Secondary:   Hematoma Formation   [ Time Frame: Up to 3 months ]

6.  Secondary:   Excessive Wound Drainage   [ Time Frame: Up to 3 months ]

7.  Secondary:   Death Rate   [ Time Frame: Up to 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Overall patient compliance for the study was low


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Joel Mayerson, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-4420
e-mail: joel.mayerson@osumc.edu



Responsible Party: Joel Mayerson, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01696760     History of Changes
Other Study ID Numbers: OSU-10055
NCI-2012-00894 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: September 27, 2012
First Posted: October 1, 2012
Results First Submitted: June 4, 2014
Results First Posted: July 4, 2014
Last Update Posted: July 4, 2014