NCT00264095

Brief Summary

The purpose of this study is to observe the methods used to manage blood loss in surgical procedures to remove tumors from patients with cancer and to determine if there is a relationship with the need for blood transfusions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
488

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

11 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

April 28, 2014

Status Verified

April 1, 2014

Enrollment Period

1.6 years

First QC Date

December 9, 2005

Last Update Submit

April 25, 2014

Conditions

AnemiaBlood Loss, SurgicalNeoplasms

Keywords

AnemiaBlood lossTransfusionBlood transfusionErythropoietinSurgerySurgical blood lossTumorCancerSurgical resectionTumor resection

Outcome Measures

Primary Outcomes (1)

  • Patients' medical history; tumor stage; type/site of operation; anticipated vs. actual blood loss; hemoglobin/hematocrit values prior to surgery, blood-saving techniques used; number of units and types of blood transfusions up to 24 hours after surgery

    24 hours after surgery

Secondary Outcomes (1)

  • Frequency of use of different blood-saving techniques for the various types of operations performed from each of the centers participating in the study

    within 24 hours after surgery

Study Arms (1)

001

Procedure: Oncological surgery

Interventions

Oncological surgeryPROCEDURE

surgery is primary observed intervention and blood loss is between 500-3000 ml

001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a malignant tumour for which surgery is the primary treatment and a minimal blood loss of 500 ml. and a maximum blood loss of 3000 ml. is expected.

You may qualify if:

  • Patients with a malignant tumor for which surgery is the first treatment
  • Having an expected blood loss of at least 500 ml (100 teaspoons), and not more than 3000 ml (600 teaspoons)

You may not qualify if:

  • Patients with a malignant tumor for which surgery is not the first treatment (i.e. have received chemotherapy first)
  • Inability to speak, read and write Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Alkmaar, Netherlands

Location

Unknown Facility

Amersfoort, Netherlands

Location

Unknown Facility

Apeldoorn, Netherlands

Location

Unknown Facility

Deventer, Netherlands

Location

Unknown Facility

Dordrecht, Netherlands

Location

Unknown Facility

Drachten, Netherlands

Location

Unknown Facility

Nieuwegein, Netherlands

Location

Unknown Facility

Nijmegen, Netherlands

Location

Unknown Facility

Roosendaal, Netherlands

Location

Unknown Facility

Sneek, Netherlands

Location

Unknown Facility

Zwolle, Netherlands

Location

MeSH Terms

Conditions

AnemiaBlood Loss, SurgicalNeoplasmsHemorrhage

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Study Officials

  • Janssen-Cilag B.V. Clinical Trial

    Janssen-Cilag B.V.

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 12, 2005

Study Start

July 1, 2004

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

April 28, 2014

Record last verified: 2014-04

Locations

NL(11)