Mild Pulmonary Function Changes With Transfusion
1 other identifier
observational
92
1 country
1
Brief Summary
The purpose of the study is to determine whether transfusion is associated with mild pulmonary changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2005
Longer than P75 for all trials
1 active site
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
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 19, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJanuary 16, 2015
January 1, 2015
6.3 years
May 19, 2008
January 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lung compliance and dead space.
Before and after transfusion
Secondary Outcomes (1)
White blood cell count before and after transfusion
Before and after transfusion
Study Arms (1)
1, 2, 3
Eligibility Criteria
The study population is all adult spine surgery patients aged 16 to 75 who are scheduled for orthopedic spine surgery at UCSF who are expected to lose at least 1000 cc of blood during their surgery and who will receive both stored blood and cell-salvaged blood during their surgery.
You may qualify if:
- Patients, male or female, any race or ethnicity, age 16-75 years, undergoing elective posterior spine surgery at University of California, San Francisco (UCSF) with expected sufficient blood loss to require intra-operative cell salvage and blood transfusion, who have donated blood for themselves preoperatively. -
You may not qualify if:
- Patients are excluded who are under 16 or over 75 year of age. Also excluded are those that have pulmonary disease, abnormal pulmonary function or gas exchange by history or physical examination, and pre-operative measurement of oxyhemoglobin saturation (percutaneous); any operative procedure within one week of study; active infection; cardiac failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Francisco
San Francisco, California, 94143, United States
Related Publications (1)
Weiskopf RB, Feiner J, Hopf H, Lieberman J, Finlay HE, Quah C, Kramer JH, Bostrom A, Toy P. Fresh blood and aged stored blood are equally efficacious in immediately reversing anemia-induced brain oxygenation deficits in humans. Anesthesiology. 2006 May;104(5):911-20. doi: 10.1097/00000542-200605000-00005.
PMID: 16645441BACKGROUND
Biospecimen
Biospecimens are retained for cytokine and inflammatory marker analyses.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Gropper, MD
University of California, San Francisco
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2008
First Posted
May 21, 2008
Study Start
October 1, 2005
Primary Completion
January 1, 2012
Study Completion
January 1, 2014
Last Updated
January 16, 2015
Record last verified: 2015-01