Trial Outcomes & Findings for PROSPER: PostpaRtum PrOphylaxiS for PE Randomized Control Trial Pilot (NCT NCT01274637)

NCT ID: NCT01274637

Last Updated: 2017-08-01

Results Overview

The average number of subjects that are recruited per site per month during a 4 month active recruitment phase at each site.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 62 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2017-08-01

Participant Flow

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.

Participant milestones

Measure	Low Molecular Weight Heparin 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.	Control Group No treatment control group.
Overall Study STARTED	30	32
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Low Molecular Weight Heparin 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.	Control Group No treatment control group.
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

PROSPER: PostpaRtum PrOphylaxiS for PE Randomized Control Trial Pilot

Baseline characteristics by cohort

Measure	Low Molecular Weight Heparin n=30 Participants 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.	Control Group n=32 Participants No treatment control group.	Total n=62 Participants Total of all reporting groups
Age, Continuous	30.0 years n=5 Participants	31.6 years n=7 Participants	30.8 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	27 participants n=5 Participants	28 participants n=7 Participants	55 participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

The average number of subjects that are recruited per site per month during a 4 month active recruitment phase at each site.

Outcome measures

Measure	Low Molecular Weight Heparin n=30 Participants 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.	Control Group n=32 Participants No treatment control group.
Feasibility of Recruitment and Trial Operations.	0.9 participants per site per month	0.9 participants per site per month

SECONDARY outcome

Timeframe: From randomization to Day 10

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.

Outcome measures

Measure	Low Molecular Weight Heparin n=30 Participants 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.	Control Group n=30 Participants No treatment control group.
Venous Thromboembolism in the Early Postpartum Period.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 10 to Day 90

This includes symptomatic Deep Vein Thrombosis or Pulmonary Embolism. Suspected outcomes will be adjudicated by a blinded adjudication committee.

Outcome measures

Measure	Low Molecular Weight Heparin n=30 Participants 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.	Control Group n=30 Participants No treatment control group.
Late Symptomatic Venous Thromboembolism	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Randomization to Day 90

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.

Outcome measures

Measure	Low Molecular Weight Heparin n=30 Participants 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.	Control Group n=32 Participants No treatment control group.
Death From Venous Thromboembolism	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Randomization to Day 90

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).

Outcome measures

Measure	Low Molecular Weight Heparin n=30 Participants 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.	Control Group n=32 Participants No treatment control group.
Major Bleeding or Clinically Relevant Non-major Bleeding	3 Participants	1 Participants

SECONDARY outcome

Timeframe: From Randomization to Day 90

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.

Outcome measures

Measure	Low Molecular Weight Heparin n=30 Participants 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.	Control Group n=32 Participants No treatment control group.
Heparin Induced Thrombocytopenia	0 Participants	0 Participants

Adverse Events

Low Molecular Weight Heparin

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Low Molecular Weight Heparin n=30 participants at risk 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.	Control Group n=32 participants at risk No treatment control group.
Pregnancy, puerperium and perinatal conditions Hospitalization	3.3% 1/30	0.00% 0/32
Infections and infestations Hospitalization	3.3% 1/30	0.00% 0/32

Other adverse events

Measure	Low Molecular Weight Heparin n=30 participants at risk 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.	Control Group n=32 participants at risk No treatment control group.
Infections and infestations Cellulitis	3.3% 1/30	0.00% 0/32
Blood and lymphatic system disorders Abnormal Lab result	3.3% 1/30	0.00% 0/32

Additional Information

Dr. Marc Rodger

Ottawa Hospital Research Institute

Phone: 6137388899

Email: mrodger@ohri.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place