## Protocol Section
### Identification Module
**NCT ID:** NCT01325779

**Brief Title:** Comparison of Subcutaneous Heparin and Enoxaparin for Deep Venous Thrombosis (DVT) Prophylaxis in Surgical Intensive Care Patients

**Official Title:** Prevention of Lower Extremity Deep Venous Thrombosis in the Surgical Intensive Care Unit: a Randomized Trial Comparing Subcutaneous Heparin and Subcutaneous Enoxaparin

#### Organization Study ID Info
**ID:** HIC 2010-113
#### Organization
**Class:** OTHER
**Full Name:** William Beaumont Hospitals
### Status Module
#### Completion Date
**Date:** 2013-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-05-20

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-05-17

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2013-02

**Type:** ACTUAL

#### Start Date
**Date:** 2011-03

**Status Verified Date:** 2013-05

#### Study First Post Date
**Date:** 2011-03-30
**Type:** ESTIMATED
**Study First Submit Date:** 2011-03-28
**Study First Submit QC Date:** 2011-03-29
**Why Stopped:** poor enrollment
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Lisa Louwers

#### Responsible Party

**Investigator Affiliation:** William Beaumont Hospitals

**Investigator Full Name:** Lisa Louwers

**Investigator Title:** Principal Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Study hypothesis: Subcutaneous enoxaparin is more effective than subcutaneous heparin in preventing the development of DVT in the general surgical intensive care unit population.

Hospitalized patients are at increased risk for the development of blood clots in the legs, known as deep venous thrombosis (DVT). Surgical patients are in a higher risk category than the general hospital population due to a number of factors including undergoing surgery and increased risk of immobility. The highest risk patients are in the surgical intensive care unit, where their surgical risks for blood clots are combined with issues such as sepsis, acquired blood clotting disorders, and increasing age, each of which are factors that contribute to the risk of blood clot development. 1. Patients who develop these blood clots (DVTs) are at risk for chronic leg swelling, pain, and in some cases, chronic ulcer development on the leg. In the worst case scenario, these blood clots can break away and migrate to the lungs where they cause a pulmonary embolism (PE), a clot in the lungs that can cause significant breathing difficulty requiring intubation and mechanical ventilation, and in some cases, death.

According to recent research, DVTs account for over 200,000 patient deaths each year nationwide. 2. A large amount of data has supported the use of medication called heparin or enoxaparin in low doses to prevent these blood clots from forming while in the hospital. Both of these medications are considered standard of care for use patients considered moderate and high risk for the development of DVT. 3. While both of these medications have been shown to significantly reduce the occurrence of DVT in appropriate doses, 4. there has never been a direct comparison of the two medications in the highest-risk population of the surgical intensive care unit. Our own preliminary data suggests patients may have a lower incidence of DVTs with the use of enoxaparin versus heparin. Part of the reason for this may be the requirement for three times daily dosing of the heparin compared to once daily dosing for enoxaparin. There may also be some inherent differences in the efficacy of the medications themselves.

### Conditions Module

**Conditions:**

- Lower Extremity Deep Venous Thrombosis

**Keywords:**

- deep venous thrombosis

- DVT

- enoxaparin

- heparin

- surgical intensive care

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: heparin

**Label:** subcutaneous heparin

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: enoxaparin

**Label:** subcutaneous enoxaparin

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- subcutaneous heparin

**Description:** subcutaneous heparin 5000 units every 8 hours

**Name:** heparin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- subcutaneous enoxaparin

**Description:** subcutaneous enoxaparin 40 milligrams every 24 hours

**Name:** enoxaparin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Development of lower extremity deep venous thrombosis

**Time Frame:** hospital admission (day 1 ) to 3 months post discharge

#### Secondary Outcomes

**Measure:** Adverse events associated with use of subcutaneous heparin and enoxaparin

**Time Frame:** hospital admission (day 1) through discharge

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* age \> 18 years old
* admission to the surgical intensive care unit
* admitting physician is a surgeon or patient is status-post a surgical procedure

Exclusion Criteria:

* age \< 18 years old
* inability to obtain informed consent from patient or legal representative within 24 hours of SICU admission
* patient admitted to neurosurgery or status-post a neurosurgical procedure
* patient status-post an orthopedic procedure
* patient admitted with a primary diagnosis of trauma
* patient with a history of a bleeding disorder or other contraindication to even low-dose anticoagulation medicine including a history of heparin-induced thrombocytopenia verified with a positive serotonin-release assay or have a high clinical suspicion of new onset heparin-induced thrombocytopenia resulting in the discontinuation of heparin or enoxaparin by the treating physicians
* patients on current full anticoagulation medications including a heparin drip or warfarin

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Royal Oak

**Country:** United States

**Facility:** William Beaumont Hospital

**State:** Michigan

**Zip:** 48073

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000016769

- Term: Embolism and Thrombosis

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M16686

- Name: Thrombosis

- Relevance: HIGH

- As Found: Thrombosis

- ID: M22071

- Name: Venous Thrombosis

- Relevance: HIGH

- As Found: Venous Thrombosis

- ID: M7784

- Name: Embolism

- Relevance: LOW

- As Found: Unknown

- ID: M19128

- Name: Embolism and Thrombosis

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013927

- Term: Thrombosis

- ID: D000020246

- Term: Venous Thrombosis

### Intervention Browse Module - Ancestors

- ID: D000000925

- Term: Anticoagulants

- ID: D000005343

- Term: Fibrinolytic Agents

- ID: D000050299

- Term: Fibrin Modulating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: FiAg

- Name: Fibrinolytic Agents

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9579

- Name: Heparin

- Relevance: HIGH

- As Found: Obesity

- ID: M20152

- Name: Enoxaparin

- Relevance: HIGH

- As Found: Below

- ID: M46053

- Name: Calcium heparin

- Relevance: LOW

- As Found: Unknown

- ID: M137075

- Name: Enoxaparin sodium

- Relevance: LOW

- As Found: Unknown

- ID: M4244

- Name: Anticoagulants

- Relevance: LOW

- As Found: Unknown

- ID: M8473

- Name: Fibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000006493

- Term: Heparin

- ID: D000017984

- Term: Enoxaparin

### Misc Info Module

- Version Holder: 2024-05-24
