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

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. Identifier: NCT00953901
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : November 16, 2009
Information provided by:
Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blood Coagulation, Disorders Surgical Procedures, Minimally Invasive Drug: Fresh Frozen Plasma Transfusion Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Restrictive Versus Liberal Fresh Frozen Plasma Transfusion Prior to Low-Risk Invasive Procedures in Hospitalized Patients.
Study Start Date : July 2006
Primary Completion Date : December 2007
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. New onset pulmonary edema

Secondary Outcome Measures :
  1. Postprocedural bleeding complications
  2. Number of blood product transfusions
  3. Hospital mortality
  4. Length of intensive care unit and hospital stay

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00953901

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic Identifier: NCT00953901     History of Changes
Other Study ID Numbers: 2247-05
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: November 16, 2009
Last Verified: November 2009