## Protocol Section
### Identification Module
**NCT ID:** NCT01576679

**Brief Title:** Safety and Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-Abdominal Collections in Children - A Prospective Study

**Official Title:** A Double Blind, Randomized Controlled Trial Examining the Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-abdominal Collections in Children - a Prospective Study

#### Organization Study ID Info
**ID:** 1000029136
#### Organization
**Class:** OTHER
**Full Name:** The Hospital for Sick Children
### Status Module
#### Completion Date
**Date:** 2017-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-06-27

**Type:** ACTUAL

**Last Update Submit Date:** 2019-06-25

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2016-05

**Type:** ACTUAL

#### Start Date
**Date:** 2012-03

**Type:** ACTUAL

**Status Verified Date:** 2019-06

#### Study First Post Date
**Date:** 2012-04-12
**Type:** ESTIMATED
**Study First Submit Date:** 2012-04-10
**Study First Submit QC Date:** 2012-04-11
**Why Stopped:** very slow accrual.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The Hospital for Sick Children

#### Responsible Party

**Investigator Affiliation:** The Hospital for Sick Children

**Investigator Full Name:** Bairbre Connolly

**Investigator Title:** Project Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The objective of this study is to establish the efficacy of tPA when used in pediatric intra-abdominal abscesses immediately after percutaneous drainage, irrespective of the ultrasound appearance or consistency of the drained fluid.

**Detailed Description:** The use of tPA in pediatric abdominal abscesses is poorly defined. The indications are somewhat subjective and the dosage guidelines vary between institutions. Some studies have suggested that it be administered at, or soon after, the time of drainage if the ultrasound appearance of the collection is complex and/or septated, or if the initial aspirated contents are thick and viscous. Both criteria are difficult to accurately define and implement. In many instances, when there is minimal ongoing drainage despite follow-up ultrasound appearances suggesting a significant residual collection, tPA is administered several days following the initial procedure.

The purpose of this study is to establish the efficacy of tPA in the initial treatment of all pediatric intra-abdominal abcesses and a standardized manner in which it can be used. This may eventually lead to a change in practice in the management of this patient population.

### Conditions Module

**Conditions:**

- Intra-abdominal Abscess

**Keywords:**

- intra-abdominal

- abscess

- tPA

- alteplase

- cathflo

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 28

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** tissue Plasminogen Activator

**Intervention Names:**

- Drug: Cathflo (Alteplase)

**Label:** tPA

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Saline

**Intervention Names:**

- Drug: Saline

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- tPA

**Name:** Cathflo (Alteplase)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Name:** Saline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The primary outcome is the length of time (in hours) the drain remains insitu.

For the primary outcome the individual abscess will be the unit of measurement; if there are multiple abscesses (up to a maximum of three) in the one patient each abscess will receive the same treatment. In the case of more than one drain being inserted in a single patient, the length of time that each drain remains in situ will be recorded individually.

**Measure:** Length of time the drain remains insitu

**Time Frame:** up to 2 weeks

#### Secondary Outcomes

**Measure:** Documentation of any adverse event

**Time Frame:** up to 2 weeks

**Measure:** The length of hospital stay

**Time Frame:** up to 2 months

**Measure:** Rate of resolution of abscess

**Time Frame:** up to 2 weeks

**Measure:** Return of clinical parameters to normal

**Time Frame:** up to 2 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. All patients under the age of 18 years with intra-abdominal bacterial abscesses requiring percutaneous drain insertion (including transrectal drains).
2. Drain(s) must be inserted within the 23hrs prior to enrollment in the study.
3. The underlying diagnosis of the condition will not affect the enrollment of the patient unless it is detailed within the exclusion criteria (section 4.1.2).
4. Patients and parents must have signed informed consent to participate in the study.

Exclusion Criteria:1.

1. Pancreatic abscess (not bacterial in nature)
2. Known coagulation impairment
3. Known central nervous system tumor or abscesses
4. Arteriovenous malformation
5. Aneurysm or history of central nervous system bleeding
6. Hypersensitivity to tPA
7. Recent administration of an investigational drug (within previous 30 days)
8. Pregnancy
9. Breast-feeding
10. Fulminant hepatic failure
11. Proven fistula (as it will alter the drainage time) or any abscess secondary to Crohn's Disease (because fistula existence cannot be excluded)
12. Necrotizing enterocolitis
13. Children requiring 4 or more drains

**Maximum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Toronto

**Country:** Canada

**Facility:** The Hospital for Sick Children

**State:** Ontario

**Zip:** M5G1X8

#### Overall Officials

**Official 1:**

**Affiliation:** The Hospital for Sick Children

**Name:** Bairbre Connolly, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013492

- Term: Suppuration

- ID: D000007239

- Term: Infections

- ID: D000007249

- Term: Inflammation

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M37

- Name: Abscess

- Relevance: HIGH

- As Found: Abscess

- ID: M20845

- Name: Abdominal Abscess

- Relevance: HIGH

- As Found: Abdominal Abscess

- ID: M16273

- Name: Suppuration

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000038

- Term: Abscess

- ID: D000018784

- Term: Abdominal Abscess

### Intervention Browse Module - Ancestors

- 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: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M13848

- Name: Plasminogen

- Relevance: LOW

- As Found: Unknown

- ID: M13849

- Name: Tissue Plasminogen Activator

- Relevance: HIGH

- As Found: Bearing

- ID: M8473

- Name: Fibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000010959

- Term: Tissue Plasminogen Activator

### Misc Info Module

- Version Holder: 2024-05-24
