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PROSPER: PostpaRtum PrOphylaxiS for PE Randomized Control Trial Pilot (PROSPER)

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ClinicalTrials.gov Identifier: NCT01274637
Recruitment Status : Completed
First Posted : January 11, 2011
Results First Posted : August 1, 2017
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Venous Thromboembolism
Postpartum
Intervention Drug: Dalteparin Sodium
Enrollment 62
Recruitment Details Potential subjects were initially approached by a member of the health care team providing their care (physician, nurse, care facilitator, etc.). If the patient agreed to being contacted, the Investigator or designate provided detailed information regarding the study and assessed the individual's eligibility for the study.
Pre-assignment Details  
Arm/Group Title Low Molecular Weight Heparin Control Group
Hide Arm/Group Description

Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.

Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes.

No treatment control group.
Period Title: Overall Study
Started 30 32
Completed 30 30
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             1
Lost to Follow-up             0             1
Arm/Group Title Low Molecular Weight Heparin Control Group Total
Hide Arm/Group Description

Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.

Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes.

No treatment control group. Total of all reporting groups
Overall Number of Baseline Participants 30 32 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants 32 participants 62 participants
30.0
(20 to 43)
31.6
(18 to 38)
30.8
(18 to 43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
Female
30
 100.0%
32
 100.0%
62
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
Hispanic or Latino
2
   6.7%
2
   6.3%
4
   6.5%
Not Hispanic or Latino
28
  93.3%
30
  93.8%
58
  93.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.3%
2
   6.3%
3
   4.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  13.3%
3
   9.4%
7
  11.3%
White
24
  80.0%
27
  84.4%
51
  82.3%
More than one race
1
   3.3%
0
   0.0%
1
   1.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
Canada 27 28 55
United States 3 4 7
1.Primary Outcome
Title Feasibility of Recruitment and Trial Operations.
Hide Description The average number of subjects that are recruited per site per month during a 4 month active recruitment phase at each site.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Molecular Weight Heparin Control Group
Hide Arm/Group Description:

Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.

Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes.

No treatment control group.
Overall Number of Participants Analyzed 30 32
Measure Type: Number
Unit of Measure: participants per site per month
0.9 0.9
2.Secondary Outcome
Title Venous Thromboembolism in the Early Postpartum Period.
Hide Description This includes symptomatic Deep Vein Thrombosis (DVT) or pulmonary embolism (PE) in the interval between randomization and the last dose of study drug (10 days +/- 3 days) OR asymptomatic proximal DVT detected by compression ultrasound of both legs done within 24hrs of the last dose of study drug (10 days (+/- 3 days) postpartum). Compressed and non-compressed images will be obtained from the calf trifurcation to the inguinal ligament. All suspected outcomes will be adjudicated by a blinded expert adjudication committee.
Time Frame From randomization to Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Molecular Weight Heparin Control Group
Hide Arm/Group Description:

Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.

Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes.

No treatment control group.
Overall Number of Participants Analyzed 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Late Symptomatic Venous Thromboembolism
Hide Description This includes symptomatic Deep Vein Thrombosis or Pulmonary Embolism. Suspected outcomes will be adjudicated by a blinded adjudication committee.
Time Frame From Day 10 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Molecular Weight Heparin Control Group
Hide Arm/Group Description:

Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.

Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes.

No treatment control group.
Overall Number of Participants Analyzed 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Death From Venous Thromboembolism
Hide Description

If a subject dies between randomization and late postpartum follow up (Day 90 +/- 7 days) the death will be adjudicated as certain, highly probable, probable, or unlikely due to Pulmonary Embolism (PE) using the following criteria.

Certain: hypotension, hypoxia, cardiac arrest with no other explanation other than PE and autopsy or radiographic confirmation Highly probable: criteria for certain but another disease could have caused the death Probable: other cause suspected based on clinical evidence but 100% certainty not available Unlikely: all other cases.

Time Frame From Randomization to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Molecular Weight Heparin Control Group
Hide Arm/Group Description:

Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.

Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes.

No treatment control group.
Overall Number of Participants Analyzed 30 32
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Major Bleeding or Clinically Relevant Non-major Bleeding
Hide Description

Major bleeding meets at least one of the following: Fatal bleeding; Symptomatic bleeding in a critical area or organ (intracranial, intraspinal, retroperitoneal, etc.); Bleeding causing a fall in hemoglobin level of 20 g L-1 (1.24 mmol L-1) or more, or leading to transfusion of two or more units of whole blood or red cells .

Clinically Relevant Non-major Bleeding does not meet the criteria for major bleeding but meets at least one of the following: Hospitalization; Medical intervention; Unscheduled contact with a physician; Discomfort (pain, or impairment of activities of daily life).

Time Frame From Randomization to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Molecular Weight Heparin Control Group
Hide Arm/Group Description:

Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.

Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes.

No treatment control group.
Overall Number of Participants Analyzed 30 32
Measure Type: Count of Participants
Unit of Measure: Participants
3
  10.0%
1
   3.1%
6.Secondary Outcome
Title Heparin Induced Thrombocytopenia
Hide Description All subjects who develop thrombocytopenia (platelets less than 80 x 109/L and/or with >50% decrease from baseline) will be investigated for Heparin Induced Thrombocytopenia (HIT) by having ELISA and serotonin release assays to confirm or refute a diagnosis of HIT. HIT will be diagnosed with a positive PF4 (platelet factor 4) HIT ELISA assay.
Time Frame From Randomization to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Molecular Weight Heparin Control Group
Hide Arm/Group Description:

Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.

Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes.

No treatment control group.
Overall Number of Participants Analyzed 30 32
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Molecular Weight Heparin Control Group
Hide Arm/Group Description

Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections.

Dalteparin Sodium: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes.

No treatment control group.
All-Cause Mortality
Low Molecular Weight Heparin Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Low Molecular Weight Heparin Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   2/30 (6.67%)   0/32 (0.00%) 
Infections and infestations     
Hospitalization  [1]  1/30 (3.33%)  0/32 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Hospitalization  [2]  1/30 (3.33%)  0/32 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Hospitalization for post-partum infection
[2]
Hospitalization for post-partum bleeding event
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Molecular Weight Heparin Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   3/30 (10.00%)   0/32 (0.00%) 
Blood and lymphatic system disorders     
Abnormal Lab result  [1]  1/30 (3.33%)  0/32 (0.00%) 
Infections and infestations     
Cellulitis  [2]  1/30 (3.33%)  0/32 (0.00%) 
Cellulitis  [3]  1/30 (3.33%)  0/32 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Critically low hemoglobin
[2]
Cellulitis of c-section incision
[3]
Cellulitis of left lower leg, resolving with antibiotics
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. Marc Rodger
Organization: Ottawa Hospital Research Institute
Phone: 6137388899
EMail: mrodger@ohri.ca
Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01274637    
Other Study ID Numbers: 2010303-01H
First Submitted: January 10, 2011
First Posted: January 11, 2011
Results First Submitted: January 10, 2017
Results First Posted: August 1, 2017
Last Update Posted: August 1, 2017