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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00953901
First received: August 4, 2009
Last updated: November 13, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Blood Coagulation, Disorders
Surgical Procedures, Minimally Invasive
Drug: Fresh Frozen Plasma Transfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Restrictive Versus Liberal Fresh Frozen Plasma Transfusion Prior to Low-Risk Invasive Procedures in Hospitalized Patients.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • New onset pulmonary edema

Secondary Outcome Measures:
  • Postprocedural bleeding complications
  • Number of blood product transfusions
  • Hospital mortality
  • Length of intensive care unit and hospital stay

Enrollment: 2
Study Start Date: July 2006
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00953901

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00953901     History of Changes
Other Study ID Numbers: 2247-05
Study First Received: August 4, 2009
Last Updated: November 13, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 20, 2014