A Phase 4 interventional study of Subcutaneous Heparin in Prostate Cancer, Venous Thromboembolism and Lymphocele After Surgical Procedure, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-08-05.
Sponsored by Johns Hopkins University · Phase 4, Interventional, and Prevention
The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy (RP).
The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy (RP). Currently, there is no standard practice for VTE prophylaxis after RP with the American Urological Association recommending "pharmacological or pneumatic mechanical prophylaxis" for high risk patients. Prior studies showed 30% of patients in the United States received no perioperative prophylaxis and less than 20% received pharmacologic agents, compared to 98% of patients receiving pharmacologic prophylaxis in the United Kingdom. Some urologists prescribe patients low molecular weight heparin (LMWH) after discharge for up to 30 days after surgery. Additionally, there are no established risks of pharmacologic prophylaxis for RP patients, but some urologists express concern about the potential impact of prophylaxis on the rate of postoperative lymphoceles or hematomas. At Johns Hopkins, patients do not routinely receive pharmacologic VTE prophylaxis in the perioperative setting for RP. Given the lack of standard practice and implications for patient safety, the investigators propose a prospective, stratified randomized controlled trial to evaluate the impact of perioperative pharmacologic prophylaxis on VTE following RP hypothesizing that it will prevent VTE events without significantly impacting the rate of postoperative bleeding or lymphoceles. The potential impact of surveillance bias with differential imaging between arms, effect of lymphadenectomy (yes/no and number of noted removed) or surgical approach (robotic and open), and differences by patients risk (comorbidity and VTE risk based on components of the Caprini score) or demographics will be assessed.
27 studies on the registry are indexed under Lymphocele; 3 are open to participants now.
This study's enrollment of 501 is above the median of 100 across 24 interventional studies indexed under Lymphocele.
Browse Lymphocele studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Subcutaneous Heparin
Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.
Number of Participants With Symptomatic Venous Thromboembolism
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).
Time frame: 30 days
Number of Participants With Symptomatic Postoperative Fluid Collection
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.
Time frame: 30 days
Number of Participants With Major Postoperative Bleeding
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.
Time frame: 30 days
Number of Participants With Occurrence of Any Venous Thromboembolism
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.
Time frame: 30 days
Estimated Blood Loss During Surgery
The total recorded intraoperative estimated blood loss in milliliters reported at the end of the surgery.
Time frame: During surgery (usually between 2-3 hours of operative time)
Surgical Drain Output After Surgery
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.
Time frame: Over length of stay in hospital (usually 1 to 2 days)
Surveillance Bias by Differential Use of Imaging as Assessed by Number of Participants Receiving Postoperative Diagnostic Imaging for Venous Thromboembolism Relative to Symptoms
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).
Time frame: 30 days
| Milestone | Subcutaneous Heparin | Control |
|---|---|---|
| Started | 251 | 250 |
| Voluntary ultrasound at 30 days | 141 | 137 |
| Completed | 251 | 249 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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).
| Participants | Subcutaneous Heparin | Control |
|---|---|---|
| Number of Participants With Symptomatic Venous Thromboembolism | 2 | 5 |
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.
| Participants | Subcutaneous Heparin | Control |
|---|---|---|
| Number of Participants With Symptomatic Postoperative Fluid Collection | 10 | 9 |
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.
| Participants | Subcutaneous Heparin | Control |
|---|---|---|
| Number of Participants With Major Postoperative Bleeding | 4 | 2 |
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.
| Participants | Subcutaneous Heparin | Control |
|---|---|---|
| Number of Participants With Occurrence of Any Venous Thromboembolism | 4 | 4 |
The total recorded intraoperative estimated blood loss in milliliters reported at the end of the surgery.
| milliliters | Subcutaneous Heparin | Control |
|---|---|---|
| Estimated Blood Loss During Surgery | 150 (100 to 300) | 200 (100 to 300) |
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.
| milliliters | Subcutaneous Heparin | Control |
|---|---|---|
| Surgical Drain Output After Surgery | 95 (60 to 180) | 100 (54 to 150) |
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).
| Participants | Subcutaneous Heparin | Control |
|---|---|---|
| Surveillance Bias by Differential Use of Imaging as Assessed by Number of Participants Receiving Postoperative Diagnostic Imaging for Venous Thromboembolism Relative to Symptoms | 25 | 31 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subcutaneous Heparin | 0/251 (0%) | 9/251 (3.6%) | 34/251 (13.5%) |
| Control | 0/250 (0%) | 9/250 (3.6%) | 30/250 (12%) |
| Event | Subcutaneous Heparin | Control |
|---|---|---|
| Clavien III or Greater ComplicationSurgical and medical procedures | 9/251 | 9/250 |
| Event | Subcutaneous Heparin | Control |
|---|---|---|
| Clavien I or II ComplicationSurgical and medical procedures | 34/251 | 30/250 |
| Age, Continuous(years) | Subcutaneous Heparin | Control | Total |
|---|---|---|---|
| Median | 63 (57 to 67) | 61 (56 to 67) | 62 (57 to 67) |
| Sex: Female, Male(Participants) | Subcutaneous Heparin | Control | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 251 | 250 | 501 |
| Race/Ethnicity, Customized(Participants) | Subcutaneous Heparin | Control | Total |
|---|---|---|---|
| White | 200 | 204 | 404 |
| African American | 34 | 39 | 73 |
| Hispanic | 8 | 2 | 10 |
| Asian | 9 | 5 | 14 |
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