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Is Plasma Transfusion Beneficial Prior to Low-Risk Procedures in Hospitalized Patients With Blood Clotting Abnormalities?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953901
First Posted: August 6, 2009
Last Update Posted: November 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
August 4, 2009
August 6, 2009
November 16, 2009
July 2006
December 2007   (Final data collection date for primary outcome measure)
New onset pulmonary edema
Same as current
Complete list of historical versions of study NCT00953901 on ClinicalTrials.gov Archive Site
  • Postprocedural bleeding complications
  • Number of blood product transfusions
  • Hospital mortality
  • Length of intensive care unit and hospital stay
Same as current
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Is Plasma Transfusion Beneficial Prior to Low-Risk Procedures in Hospitalized Patients With Blood Clotting Abnormalities?
Restrictive Versus Liberal Fresh Frozen Plasma Transfusion Prior to Low-Risk Invasive Procedures in Hospitalized Patients.
Blood clotting abnormalities or problems that happen during surgery ? even minor surgery ? are serious because of the possibility of serious bleeding that cannot be stopped. The current standard practice for people with clotting abnormalities is to transfuse additional blood before the surgery, in an effort to decrease bleeding problems. However, transfusing blood before the surgery is not very effective in decreasing bleeding complications. In addition, it may be associated with other complications, including fluid buildup and swelling in the lungs. For this study, a person with a mild clotting problem is defined as one with an INR (International Normalized Ratio) between 1.5 and 3. Severe clotting is defined as an INR greater than 3. This study will aim to test if limiting or restricting transfusion for those patients with severe clotting problems (an INR greater than 3) will result in fewer transfusion problems and fewer unnecessary transfusions in comparison with the current, more liberal, transfusion use for all patients with both mild and severe clotting problems (an INR greater than 1.5).The investigators will also determine if liberal blood transfusion decreases the risk of bleeding after surgical procedures.
While the restrictive red cell transfusion practice has become a standard of care in the acutely ill, data on the use of fresh frozen plasma (FFP) are limited. FFP transfusion may not only be poorly effective in prevention of bleeding complications but is associated with significant complications. In a retrospective cohort of critically ill non-surgical patients with abnormal international normalized ratio (INR), we have observed significant variability in the practice of FFP transfusion. Rather than a benefit with liberal use, more adverse effects were observed, in particular pulmonary edema and acute lung injury. Our overall goal is to improve the safety of blood product transfusion and prevent pulmonary complications. Here we propose a randomized clinical trial of restrictive (INR 1.6-3) versus liberal (FFP transfusion to keep INR < 1.6) FFP transfusion prior to commonly performed invasive procedures (thoracocentesis, abdominal paracentesis and central venous cannulation). We will use the following outcome measures to compare the differences between the two groups: 1. New onset pulmonary edema; 2. Postprocedural bleeding complications; 3. Number of blood product transfusions; 4. Hospital mortality and 5. Length of intensive care unit and hospital stay. The results of this study will form the basis for future multicenter clinical trials with implications for worldwide transfusion practice.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Blood Coagulation, Disorders
  • Surgical Procedures, Minimally Invasive
Drug: Fresh Frozen Plasma Transfusion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
December 2008
December 2007   (Final data collection date for primary outcome measure)

Inclusion:

  • Consenting hospitalized adult
  • (>18 years)
  • Patients with abnormal INR (INR 1.6-3) due to either vitamin K depletion or antagonism (Coumadin and/or broad spectrum antibiotics) or liver insufficiency
  • Patients who are about to undergo one of the three common minimally invasive procedures (thoracocentesis, abdominal paracentesis, and central vein cannulation)

Exclusion:

Sexes Eligible for Study: All
1 Year and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00953901
2247-05
Not Provided
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Mayo Clinic
Not Provided
Not Provided
Mayo Clinic
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP