## Protocol Section
### Identification Module
**NCT ID:** NCT00868179

**Brief Title:** A Cohort Study With 100 Subjects Having a Primary Total Knee Replacement, Taking Pradax Post Discharge for Ten Days

**Official Title:** A Cohort (Follow Up) Study With 100 Subjects Having a Primary Total Knee Replacement, Taking Pradax (Tablet) Post Discharge for Ten Days, Without the Need for Routine Coagulation Monitoring and Dose Adjustment

#### Organization Study ID Info
**ID:** Pradax
#### Organization
**Class:** OTHER
**Full Name:** Nova Scotia Health Authority
### Status Module
#### Completion Date
**Date:** 2012-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-11-14

**Type:** ACTUAL

**Last Update Submit Date:** 2022-11-08

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2012-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2009-04

**Status Verified Date:** 2022-11

#### Study First Post Date
**Date:** 2009-03-24
**Type:** ESTIMATED
**Study First Submit Date:** 2009-03-23
**Study First Submit QC Date:** 2009-03-23
**Why Stopped:** study never started
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Nova Scotia Health Authority

#### Lead Sponsor

**Class:** OTHER

**Name:** Ross Leighton

#### Responsible Party

**Investigator Affiliation:** Nova Scotia Health Authority

**Investigator Full Name:** Ross Leighton

**Investigator Title:** Orthopedic Surgeon

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Currently standard of care for preventing blood clots in total knee replacement patients is the drug Fragmin which is a daily injection for 10 days after surgery. Patients are in hospital for 3 to 5 days after total knee replacement surgery and patients are taught in hospital to do their injections.

The investigators would like to introduce the drug Pradax. Pradax is a Health Canada approved once a day, oral drug that may prevent blood clots in the patient's leg. In this study the patient will receive the standard of care injection drug Fragmin while in hospital but on discharge home the patient will take the oral drug Pradax daily (2 tablets 110mg) for 10 days.

**Detailed Description:** We will enroll one hundred patients who are scheduled to have a total knee replacement. If you have signed the consent form for this study you will receive the standard of care treatment for blood clots, which is a daily injection drug called Fragmin. On the day of discharge from hospital study patients will receive a ten day supply of oral Pradax. to be taken once a day. The Orthopaedic research coordinator will call the study patients at post discharge day three and five to check on compliance and or concerns. All total knee replacement patients whether in study or not are seen in the Orthopaedic clinic at post op day 10 for staple removal and again at the 6 week point, 3 month, and 6 month and 1 year point. Standard of care x-rays are done also at these visits.

### Conditions Module

**Conditions:**

- Thromboembolism

**Keywords:**

- Thrombosis

- total knee replacement

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This is the only arm in the study and all will follow the same protocol for the study which is taking the pradax after total knee replacement

**Intervention Names:**

- Drug: Pradax

**Label:** Pradax

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pradax

**Description:** Pradax (dabigatran etexilate) is a prodrug that when converted to the active from in the liver and plasma it becomes a reversible, competitive direct thrombin inhibitor. Thrombin catalyses the conversion of soluble fibrinogen into soluble fibrin, the final step in the coagulation cascade. Pradax competitively blocks the active site of both free and clot-bound thrombin, preventing the development of a thrombus. they will take 110 mg 1-4 hours post op. and 220mg daily until 10 days post op.

**Name:** Pradax

**Other Names:**

- Pradax dabigatran etexilate

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** The primary efficacy outcome will be the clinical evidence of any deep vein thrombosis, non-fatal pulmonary embolism or death from any causes within 28 days after surgery. The primary safety outcome is major bleeding

**Time Frame:** 28 day post op and 6 months radiograophically

#### Secondary Outcomes

**Measure:** Secondary efficacy end points will be the radiographic assessment of healing, the clinical assessment of weight-¬bearing status at 6 months post treatment, and the incidence of additional surgical/medical interventions to promote healing.

**Time Frame:** 6 Months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients are eligible for the study if they are adult age, being greater than 18 years of age and less than 95 years of age. They must have the indications for a total knee replacement and have sufficiently passed the medically necessary tests by their surgeon to warrant total knee replacement.

Exclusion Criteria:

* Patients with active bleeding, or high risk of bleeding that contra-indicates the use of Pradax
* Renal or liver contra-indication necessitating adjustments of its dose.
* Clinically significant liver disease,
* Concomitant use of Proteus Ace inhibitors
* The use of the human immunitive deficiency virus
* The use of fibrinolynic agents
* Planned intermittent pneumatic compression or requirement of ongoing anticoagulation therapy
* Pregnancy
* Breast-feeding.

**Maximum Age:** 95 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Halifax

**Country:** Canada

**Facility:** Halifax Infirmary

**State:** Nova Scotia

**Zip:** B3h 1V7

#### Overall Officials

**Official 1:**

**Affiliation:** Nova Scotia Health Authority

**Name:** Ross K Leighton, MD FRCSC

**Role:** PRINCIPAL_INVESTIGATOR

## 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: M16682

- Name: Thromboembolism

- Relevance: HIGH

- As Found: Thromboembolism

- ID: M16686

- Name: Thrombosis

- Relevance: LOW

- As Found: Unknown

- 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: D000013923

- Term: Thromboembolism

### Intervention Browse Module - Ancestors

- ID: D000000991

- Term: Antithrombins

- ID: D000015842

- Term: Serine Proteinase Inhibitors

- ID: D000011480

- Term: Protease Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000925

- Term: Anticoagulants

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: Coag

- Name: Coagulants

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M490

- Name: Dabigatran

- Relevance: HIGH

- As Found: Must

- ID: M16676

- Name: Thrombin

- Relevance: LOW

- As Found: Unknown

- ID: M4307

- Name: Antithrombins

- Relevance: LOW

- As Found: Unknown

- ID: M4306

- Name: Antithrombin III

- Relevance: LOW

- As Found: Unknown

- ID: M14343

- Name: Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M18391

- Name: Serine Proteinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19609

- Name: HIV Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4244

- Name: Anticoagulants

- Relevance: LOW

- As Found: Unknown

- ID: T18

- Name: Serine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069604

- Term: Dabigatran

### Misc Info Module

- Version Holder: 2024-05-24
