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Trial record 23 of 56 for:    "Lung Disease" | "Dalteparin"

A Different Approach to Preventing Thrombosis (ADAPT)

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ClinicalTrials.gov Identifier: NCT02774265
Recruitment Status : Completed
First Posted : May 17, 2016
Results First Posted : July 24, 2018
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Deborah Stein, University of Maryland, College Park

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Venous Thromboembolism
Pulmonary Embolism
Interventions Drug: VTE prophylaxis with Enoxaparin 30mg BID
Drug: VTE prophylaxis with Aspirin 81mg BID
Enrollment 329
Recruitment Details We recruited inpatients admitted between January 19, 2016 and November 1, 2016.
Pre-assignment Details  
Arm/Group Title VTE Prophylaxis With Enoxaparin 30mg BID VTE Prophylaxis With Aspirin 81mg BID
Hide Arm/Group Description

The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.

VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.

The group receiving VTE prophylaxis with ASA 81mg PO BID

VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.

Period Title: Overall Study
Started 164 165
Completed 151 159
Not Completed 13 6
Arm/Group Title VTE Prophylaxis With Enoxaparin 30mg BID VTE Prophylaxis With Aspirin 81mg BID Total
Hide Arm/Group Description

The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.

VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.

The group receiving VTE prophylaxis with ASA 81mg PO BID

VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.

Total of all reporting groups
Overall Number of Baseline Participants 164 165 329
Hide Baseline Analysis Population Description
Analysis is the same as the assignment in Participant Flow
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 165 participants 329 participants
45.4  (20.4) 48  (18.6) 46.7  (19.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 165 participants 329 participants
Female
45
  27.4%
61
  37.0%
106
  32.2%
Male
119
  72.6%
104
  63.0%
223
  67.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 165 participants 329 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
53
  32.3%
45
  27.3%
98
  29.8%
White
97
  59.1%
106
  64.2%
203
  61.7%
More than one race
6
   3.7%
3
   1.8%
9
   2.7%
Unknown or Not Reported
8
   4.9%
11
   6.7%
19
   5.8%
Current smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 165 participants 329 participants
62
  37.8%
65
  39.4%
127
  38.6%
1.Primary Outcome
Title Number of Participants With Treatment-related Bleeding Events as Assessed by the Need for Blood Transfusions and Procedures for Bleeding Complications After Initiation of the Study Medication.
Hide Description Includes a greater than 2g/dL drop in hemoglobin, blood transfusion, hematoma evacuation, re-operation for a deep surgical site infection or minor procedure for bleeding and GI bleed
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
As described in Participant Flow
Arm/Group Title VTE Prophylaxis With Enoxaparin 30mg BID VTE Prophylaxis With Aspirin 81mg BID
Hide Arm/Group Description:

The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.

VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.

The group receiving VTE prophylaxis with ASA 81mg PO BID

VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.

Overall Number of Participants Analyzed 164 165
Measure Type: Count of Participants
Unit of Measure: Participants
52
  31.7%
53
  32.1%
2.Secondary Outcome
Title Number of Participants With Deep Venous Thromboembolism
Hide Description DVT and how the diagnosis was made will be recorded. The number of events in participants in each arm will be compared to evaluate efficacy.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
same as flow chart
Arm/Group Title VTE Prophylaxis With Enoxaparin 30mg BID VTE Prophylaxis With Aspirin 81mg BID
Hide Arm/Group Description:

The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.

VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.

The group receiving VTE prophylaxis with ASA 81mg PO BID

VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.

Overall Number of Participants Analyzed 164 165
Measure Type: Count of Participants
Unit of Measure: Participants
5
   3.0%
9
   5.5%
3.Secondary Outcome
Title Number of Participants With Pulmonary Embolism Events
Hide Description Bases on imaging obtained for symptoms.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
As per flow sheet
Arm/Group Title VTE Prophylaxis With Enoxaparin 30mg BID VTE Prophylaxis With Aspirin 81mg BID
Hide Arm/Group Description:

The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.

VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.

The group receiving VTE prophylaxis with ASA 81mg PO BID

VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.

Overall Number of Participants Analyzed 164 165
Measure Type: Count of Participants
Unit of Measure: Participants
6
   3.7%
2
   1.2%
Time Frame 90 days post injury
Adverse Event Reporting Description Adverse events as described by our IRB reporting protocol include only unexpected adverse events. Since study outcomes like bleeding and venous thromboembolism are expected, measured outcomes, these are not included.
 
Arm/Group Title VTE Prophylaxis With Enoxaparin 30mg BID VTE Prophylaxis With Aspirin 81mg BID
Hide Arm/Group Description

The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.

VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.

The group receiving VTE prophylaxis with ASA 81mg PO BID

VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.

All-Cause Mortality
VTE Prophylaxis With Enoxaparin 30mg BID VTE Prophylaxis With Aspirin 81mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   3/164 (1.83%)   3/165 (1.82%) 
Show Serious Adverse Events Hide Serious Adverse Events
VTE Prophylaxis With Enoxaparin 30mg BID VTE Prophylaxis With Aspirin 81mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   0/164 (0.00%)   0/165 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VTE Prophylaxis With Enoxaparin 30mg BID VTE Prophylaxis With Aspirin 81mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   0/164 (0.00%)   0/165 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bryce Haac
Organization: University of Maryland Medical Center
Phone: 410-328-3495
EMail: bhaac@som.umaryland.edu
Publications:
Layout table for additonal information
Responsible Party: Deborah Stein, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT02774265     History of Changes
Other Study ID Numbers: HP-00065750
First Submitted: May 10, 2016
First Posted: May 17, 2016
Results First Submitted: June 27, 2018
Results First Posted: July 24, 2018
Last Update Posted: September 27, 2019