NCT00866268

Brief Summary

Principal hypothesis: A low suction drainage (-50 mmHg) reduce a 25% the blood loss with respect a standard closed drainage (-700 mmHg) following total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
Last Updated

March 20, 2009

Status Verified

March 1, 2009

Enrollment Period

10 months

First QC Date

March 19, 2009

Last Update Submit

March 19, 2009

Conditions

Total Knee Arthroplasty

Keywords

Blood lossTotal knee arthroplastyAdultsDrainDrainage system

Outcome Measures

Primary Outcomes (1)

  • total post-surgical blood loss (mL)

    from the moment after surgery until drainage catheter removal

Secondary Outcomes (13)

  • blood loss (mL) in the recovery unit

    24-48 h

  • Blood loss in the ward

    5-10 days

  • need for a blood transfusion according to the surgeon's criteria

    10 days

  • number of blood units required for transfusion

    10 Days

  • post-surgical pain (using a 100mm visual analogue scale)

    10 days

  • +8 more secondary outcomes

Study Arms (2)

Low suction drainage

EXPERIMENTAL

In the experimental group the drainage catheter was connected to a modified DRENOFAST® system. This system consisted of a sterile plastic bottle with a holding capacity of 600 mL of fluid and a negative pressure of 700mmHg. It was hermetically closed and had two connections. The DRENOFAST® modification consisted of establishing an open connection between the bottle and a wall vacuum source (normally used to administer oxygen) placed next to the patient's bed. The 50 mmHg constant negative pressure of the bottle was maintained by the wall vacuum source and verified by flow meter.

Device: low pressure suction drainage

High suction drainage

ACTIVE COMPARATOR

The standard DRENOFAST® system was used in the control group, and the initial negative pressure was 700 mmHg.

Device: High pressure suction drainage

Interventions

low pressure suction drainageDEVICE

In the experimental group the drainage catheter was connected to a modified DRENOFAST® system. This system consisted of a sterile plastic bottle with a holding capacity of 600 mL of fluid and a negative pressure of 700mmHg. It was hermetically closed and had two connections. The DRENOFAST® modification consisted of establishing an open connection between the bottle and a wall vacuum source (normally used to administer oxygen) placed next to the patient's bed. The 50 mmHg constant negative pressure of the bottle was maintained by the wall vacuum source and verified by flow meter. Duration: Drains were removed after bleeding had ceased (48-72h).

Also known as: DRENOFAST® modified
Low suction drainage
High pressure suction drainageDEVICE

In order to mask the type of intervention from the patient and the investigators, both drainage systems had two drain catheters. One catheter allowed the blood to flow from the wound to the bottle. The second catheter connected the bottle to the vacuum source. In the experimental arm the second catheter was open, while in the control group it was closed. So that the system used could not be distinguished, the connection of the second catheter to the bottle was covered with opaque adhesive tape.Drains were removed after bleeding had ceased.

Also known as: DRENOFAST® system
High suction drainage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult knee replacement patients who agreed to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

Location

Orthopedic and Traumatology Service. Hospital de la Santa Creu i Sant Pau.

Barcelona, Catalonia, 08025, Spain

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Calvo Rafael, Rn

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 20, 2009

Study Start

May 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

March 20, 2009

Record last verified: 2009-03

Locations

ES(2)