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Trial record 36 of 56 for:    "Lung Disease" | "Dalteparin"

Comparing Anti-XA Levels in Post-Cesarean Patients Undergoing Enoxaparin Thromboprophylaxis

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ClinicalTrials.gov Identifier: NCT02070237
Recruitment Status : Completed
First Posted : February 25, 2014
Results First Posted : November 23, 2015
Last Update Posted : November 23, 2015
Sponsor:
Information provided by (Responsible Party):
MemorialCare Health System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Obesity
Obesity, Morbid
Pregnancy
Complications; Cesarean Section
Venous Thromboembolism
Postpartum Deep Phlebothrombosis
Pulmonary Embolism
Intervention Drug: Enoxaparin
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enoxaparin Once Daily Enoxaparin Twice Daily
Hide Arm/Group Description

This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.

Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.

This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.

Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.

Period Title: Overall Study
Started 45 45
Completed 42 42
Not Completed 3 3
Arm/Group Title Enoxaparin Once Daily Enoxaparin Twice Daily Total
Hide Arm/Group Description

This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.

Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.

This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.

Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.

Total of all reporting groups
Overall Number of Baseline Participants 45 45 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
 100.0%
45
 100.0%
90
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 45 participants 90 participants
33  (6.6) 30  (5.4) 32  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Female
45
 100.0%
45
 100.0%
90
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 45 participants 90 participants
45 45 90
1.Primary Outcome
Title Anti Xa Level
Hide Description Our primary outcome will be to assess the Anti Xa level drawn 3.5-4 hours after the third dose of Lovenox (enoxaparin) to assess if this is in the prophylactic range.
Time Frame 3.5-4 hours after the third dose of Lovenox (enoxaparin)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enoxaparin Once Daily Enoxaparin Twice Daily
Hide Arm/Group Description:

This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.

Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.

This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.

Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.

Overall Number of Participants Analyzed 42 42
Mean (95% Confidence Interval)
Unit of Measure: IU/mL
0.14
(0.12 to 0.16)
0.30
(0.27 to 0.31)
2.Secondary Outcome
Title Supraprophylactic Range Anti Xa Level
Hide Description We will assess if any of the subjects has an Anti Xa level that is in the supraprophylactic range (treatment range).
Time Frame 3.5-4 hours after the third dose of Lovenox (enoxaparin)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enoxaparin Once Daily Enoxaparin Twice Daily
Hide Arm/Group Description:

This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.

Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.

This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.

Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.

Overall Number of Participants Analyzed 42 42
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enoxaparin Once Daily Enoxaparin Twice Daily
Hide Arm/Group Description

This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.

Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.

This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.

Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.

All-Cause Mortality
Enoxaparin Once Daily Enoxaparin Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Enoxaparin Once Daily Enoxaparin Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/42 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enoxaparin Once Daily Enoxaparin Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/42 (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. Jennifer McNulty
Organization: Memorial Care
Phone: 562-933-2730
EMail: jjmcnulty@sbcglobal.net
Layout table for additonal information
Responsible Party: MemorialCare Health System
ClinicalTrials.gov Identifier: NCT02070237     History of Changes
Other Study ID Numbers: 159-12
First Submitted: February 20, 2014
First Posted: February 25, 2014
Results First Submitted: September 23, 2015
Results First Posted: November 23, 2015
Last Update Posted: November 23, 2015