Trial Outcomes & Findings for PREvention of VENous ThromboEmbolism Following Radical Prostatectomy (NCT NCT03006562)

NCT ID: NCT03006562

Last Updated: 2020-08-05

Results Overview

Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). The primary outcome is diagnosis of DVT or PE within 30 days after surgery due to imaging (any method, most commonly lower extremity ultrasound or computed tomography scan with pulmonary embolus protocol) prompted by symptoms of a DVT (lower extremity swelling, pain, fever of unknown origin) or PE (chest pain, shortness of breath, hypoxemia, tachycardia or fever of unknown origin, productive cough with bloody sputum).

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 501 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2020-08-05

Participant Flow

Participant milestones

Measure	Subcutaneous Heparin Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge. Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.	Control Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
Overall Study STARTED	251	250
Overall Study Voluntary Ultrasound at 30 Days	141	137
Overall Study COMPLETED	251	249
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Subcutaneous Heparin Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge. Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.	Control Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

PREvention of VENous ThromboEmbolism Following Radical Prostatectomy

Baseline characteristics by cohort

Measure	Subcutaneous Heparin n=251 Participants Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge. Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.	Control n=250 Participants Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.	Total n=501 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	61 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	251 Participants n=5 Participants	250 Participants n=7 Participants	501 Participants n=5 Participants
Race/Ethnicity, Customized White	200 Participants n=5 Participants	204 Participants n=7 Participants	404 Participants n=5 Participants
Race/Ethnicity, Customized African American	34 Participants n=5 Participants	39 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: One participant in the control arm was lost to follow-up precluding outcome assessment.

Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). The primary outcome is diagnosis of DVT or PE within 30 days after surgery due to imaging (any method, most commonly lower extremity ultrasound or computed tomography scan with pulmonary embolus protocol) prompted by symptoms of a DVT (lower extremity swelling, pain, fever of unknown origin) or PE (chest pain, shortness of breath, hypoxemia, tachycardia or fever of unknown origin, productive cough with bloody sputum).

Outcome measures

Measure	Subcutaneous Heparin n=251 Participants Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge. Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.	Control n=249 Participants Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
Number of Participants With Symptomatic Venous Thromboembolism	2 Participants	5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: One participant in the control arm was lost to follow-up precluding outcome assessment.

This outcome is defined as a surgical or pelvic fluid collection diagnosed as a hematoma (blood collection, with or without infection) or lymphocele (collection of lymph fluid in the pelvis) due to symptoms (fever, abdominal pain, nausea or vomiting, anemia, high surgical drain output) within 30 days after surgery.

Outcome measures

Measure	Subcutaneous Heparin n=251 Participants Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge. Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.	Control n=249 Participants Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
Number of Participants With Symptomatic Postoperative Fluid Collection	10 Participants	9 Participants

PRIMARY outcome

Timeframe: 30 days

Population: One participant in the control arm was lost to follow-up precluding outcome assessment.

This additional primary outcome includes the development and diagnosis of any major clinically recognized bleeding event within 30 days after surgery requiring >1 unit of packed red blood cell transfusion, intervention to stop bleeding, or return to the operating room.

Outcome measures

Measure	Subcutaneous Heparin n=251 Participants Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge. Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.	Control n=249 Participants Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
Number of Participants With Major Postoperative Bleeding	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Only the subset receiving ultrasound are analyzed for this outcome.

DVT or PE diagnosed for any reason within 30 days after surgery. This includes any diagnosed DVT or PE as described in the primary outcome plus any additional DVTs or PEs diagnosed at 30 day screening lower extremity ultrasound for patients opting to undergo screening bilateral lower extremity Duplex ultrasound at 30 days who do not have symptoms.

Outcome measures

Measure	Subcutaneous Heparin n=141 Participants Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge. Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.	Control n=137 Participants Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
Number of Participants With Occurrence of Any Venous Thromboembolism	4 Participants	4 Participants

SECONDARY outcome

Timeframe: During surgery (usually between 2-3 hours of operative time)

The total recorded intraoperative estimated blood loss in milliliters reported at the end of the surgery.

Outcome measures

Measure	Subcutaneous Heparin n=251 Participants Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge. Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.	Control n=250 Participants Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
Estimated Blood Loss During Surgery	150 milliliters Interval 100.0 to 300.0	200 milliliters Interval 100.0 to 300.0

SECONDARY outcome

Timeframe: Over length of stay in hospital (usually 1 to 2 days)

The total output in milliliters from any surgical drain left in place (not all patients will necessarily have a surgical drain) after surgery and until discharge from the hospital (usually 1 to 2 days). Drain output, if one is left in place after discharge, will not count toward this secondary outcome.

Outcome measures

Measure	Subcutaneous Heparin n=251 Participants Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge. Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.	Control n=250 Participants Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
Surgical Drain Output After Surgery	95 milliliters Interval 60.0 to 180.0	100 milliliters Interval 54.0 to 150.0

SECONDARY outcome

Timeframe: 30 days

Population: One participant in the control arm was lost to follow-up precluding outcome assessment.

Patients in each arm receiving postoperative diagnostic imaging for venous thromboembolism relative to symptoms (e.g. lower extremity Duplex ultrasound, spiral CT angiography, V/Q scan).

Outcome measures

Measure	Subcutaneous Heparin n=251 Participants Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge. Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.	Control n=249 Participants Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
Surveillance Bias by Differential Use of Imaging as Assessed by Number of Participants Receiving Postoperative Diagnostic Imaging for Venous Thromboembolism Relative to Symptoms	25 Participants	31 Participants

Adverse Events

Subcutaneous Heparin

Serious events: 9 serious events

Other events: 34 other events

Deaths: 0 deaths

Control

Serious events: 9 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Subcutaneous Heparin n=251 participants at risk Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge. Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.	Control n=250 participants at risk Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
Surgical and medical procedures Clavien III or Greater Complication	3.6% 9/251 • Number of events 9 • 30 days Clavien-Dindo Complications	3.6% 9/250 • Number of events 9 • 30 days Clavien-Dindo Complications

Other adverse events

Measure	Subcutaneous Heparin n=251 participants at risk Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge. Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.	Control n=250 participants at risk Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
Surgical and medical procedures Clavien I or II Complication	13.5% 34/251 • Number of events 34 • 30 days Clavien-Dindo Complications	12.0% 30/250 • Number of events 30 • 30 days Clavien-Dindo Complications

Additional Information

Dr. Mohamad Allaf

Johns Hopkins Brady Urological Institute

Phone: 410-955-6100

Email: mallaf@jhmi.edu

Results disclosure agreements

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