Blood Coagulation DisordersPhase 3NCT00233246
Fresh-Frozen Plasma Infusions to Reduce Risk of Bleeding Related to Invasive Procedures
A Phase 3 study testing FFP Infusion in people with Blood Coagulation Disorders, run by Massachusetts General Hospital at 15 sites in United States.
Trial summary
This study will compare patients with mild to moderate prolongation of the INR test who receive FFP infusions prior to invasive hepatobiliary procedures for bleeding complications to patients who do not receive FFP infusions. Bleeding complications will be defined as meeting one or more of the following: 1. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Blood Coagulation Disorders
- What is being tested?
- FFP Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 15 sitesUnited States
- Study dates
- Mar 2006to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergoing one of the following percutaneous abdominal or transjugular invasive procedures: liver biopsy; liver-biliary abscess drainage; biliary tree drainage; or radio-frequency ablation of hepatic tumor
- Platelet count greater than or equal to 70,000/microliter
- INR greater than or equal to 1.3 and less than or equal to 1.9 (must not be based on a sample drawn within 24 hours of any prior FFP treatment)
- A PTT less than or equal to 50 sec
Who cannot join
- Use of warfarin, heparin, low molecular weight heparin, or other anticoagulant therapy within 5 days of the planned procedure (exceptions: prophylactic heparin injections into central venous catheters for catheter maintenance, prophylactic heparin (standard or low-dose) for prevention of deep venous thrombosis, and/or aspirin)
- History of severe allergic reaction to plasma products
- Use of any of the following second-generation anti-platelet agents: abciximab, tirofiban, clopidogrel, or ticlopidine
- Currently receiving any dialysis
- History of clinically significant bleeding diathesis, including Hemophilia A or B, von Willebrand's Disease, or congenital Factor VII deficiency
- Known history of a coagulation-factor inhibitor within the month prior to the procedure (In the absence of a known history, testing is not required)
Show all 9Show fewer
- Active major bleeding; bleeding from gastrointestinal, pulmonary, mouth/throat, genito-urinary tract, or central nervous system sites (excludes guaiac positive stool sample without gross blood or melena, minor epistaxis, minor gum bleeding, microscopic hematuria, superficial bruises, normal menses, or minor vaginal spotting)
- Pediatric patients requiring sedation in order to undergo a post-procedure ultrasound examination
- Already received FFP in the 24 hours before the planned invasive procedure
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Emory University
Atlanta, Georgia, 30322
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina Hospital
Chapel Hill, North Carolina, 27514
University of Texas SW Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Blood Center of SE Wisconsin
Milwaukee, Wisconsin, 53201
University of Minnesota
Minneapolis, Minnesota, 55455
Weill Medical College of Cornell University
New York, New York, 10021
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Presbyterian and Shadyside Hospital
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Puget Sound Blood Center Div of Research
Seattle, Washington, 98104
About this study
Official title: Study of Hemostasis and Invasive Procedures (SHIP: A TMH CTN Study)
This study will compare patients with mild to moderate prolongation of the INR test who receive FFP infusions prior to invasive hepatobiliary procedures for bleeding complications to patients who do not receive FFP infusions. Bleeding complications will be defined as meeting one or more of the following:
- Intrahepatic hematoma greater than 1 ml/kg of patient weight as seen on post-procedure ultrasound examination performed between 4 to 30 hours after the procedure.
- Greater than 1.6g/dL hemoglobin decline measured within 4 to 30 hours post-procedure compared with the pre-procedure value, in the absence of another identified bleeding source to account for the hemoglobin drop.
- Need for transfusion of packed red blood cells for procedure-related bleeding while in the study.
The secondary endpoints of this study will be: 1) The need to perform subsequent procedures (angiography, embolization, additional imaging study including computerized tomography (CT) scan, surgery) to diagnose or to arrest procedure-related bleeding OR the need for subsequent medical therapies (FFP, coagulation factor concentrates, anti-fibrinolytics) to treat procedure-related bleeding between time of procedure and the end of patient's time in the study. If necessary, the relationship of procedure or therapy to procedure-related bleeding will be assessed by an adjudication panel; 2) The predictive value of INR; 3) The effect of study treatment on change in INR; 4) The cost of preventing one bleed; 5) The predictors of bleeding other than INR; 6) The number of transfusion-associated adverse events encountered to prevent one bleed; and 7) The effect of treatment on bleeding grade.
Read the detailed description
BACKGROUND:
It is important to determine whether or not prophylactic FFP is necessary for patients with mild to moderate elevation of the INR who require an invasive procedure. It is also important to establish whether routine pre-procedure coagulation tests are predictive of bleeding outcomes at the time of a significant invasive procedure. Although prophylactic FFP is often given to such patients before invasive procedures, there is little evidence to show that pre-procedure INR in this range is predictive of procedure-related bleeding or that prophylactic FFP reduces this risk.
DESIGN NARRATIVE:
After obtaining consent and verifying eligibility requirements, the study staff will randomize the patient to one of two treatment groups. One group will receive a prophylactic FFP infusion before the hepatobiliary procedure. The other group will not receive prophylactic FFP.
The dose of FFP will be approximately 10 ml/kg. The dose of FFP for each patient will be determined in one of two ways in accordance with local policies: 1) rounding to the nearest integer number of units (Method 1); or 2) using split units (Method 2). The method chosen may vary between patients (e.g., a physician might decide to dose adult patients by rounding to the nearest integer number of units and to dose pediatric patients using split units).
Method 1: The dose of FFP will be the number of units that comes closest to a dose of 10 ml/kg, determined as follows: nearest integer to (10 x weight in kg)/200. Decimals .5 and higher should be rounded up to the next integer. Decimals less than .5 should be rounded down (e.g., a 70 kg patient would receive 4 units, while a 69 kg patient would receive 3 units).
Method 2: The dose of FFP will be chosen in order to come as close as possible to a dose of 10 ml/kg, and can contain either full units, split units, or a combination thereof.
After the FFP infusion (if any) and within 2 hours prior to the hepatobiliary procedure, blood will be drawn for laboratory tests and for the repository. Although Study of Hemostasis and Invasive Procedures (SHIP) will not be a truly blinded study, the clinicians performing the hepatobiliary procedure and the radiology team performing the post-procedure ultrasound will not be told whether the participant received prophylactic FFP. They will also not know the results of the immediate pre-procedure Prethrombin Time (PT)/INR and Partial Thomboplastin Time (PTT) tests.
Participants in the study may not be treated with any other systemic hemostatic agents prior to the procedure. Local hemostatic treatments may be used during the procedure, according to standard practice. The invasive hepatobiliary procedure techniques, all other concomitant treatments and interventions, and all post-procedure treatments and interventions are at the discretion of the treating physicians. Participants will be followed for clinical evidence of bleeding and will be treated as needed for any bleeding that may occur.
Repository samples will only be used for genetic and protein tests of hemostasis, coagulation, and fibrinolysis.
SHIP is designed as a one-sided non-inferiority study. The null hypothesis is that the proportion of patients not given prophylactic FFP who meet the criteria for the bleeding endpoint is at least .04 higher than the proportion of patients given prophylactic FFP who meet the criteria for the bleeding endpoint. The goal of this study is to determine whether there is strong evidence that the difference between the two treatment plans is not that large.
- Conditions
- Blood Coagulation Disorders
- Being tested
- FFP Infusion
- Medical subject headings
- Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFP InfusionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant bleeding (measured 4 to 30 hours after invasive hepatobiliary procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startMar 2006
Why it stopped: Study never activated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Transfusion Medicine/Hemostasis Clinical Research Network
- Responsible party
- Sponsor
- Investigators
- Susan Assmann, PhD, Principal investigator, New England Research Institutes, Inc.Mark Brecher, MD, Principal investigator, University of North Carolina HospitalGeorge Buchanan, MD, Principal investigator, University of Texas SW Medical CenterJames Bussel, MD, Principal investigator, Weill Medical College of Cornell UniversityJohn Hess, MD, MPH, Principal investigator, University of Maryland, BaltimoreChristopher D. Hillyer, MD, Principal investigator, Emory UniversityBarbara Konkle, MD, Principal investigator, University of PennsylvaniaDavid Kuter, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233246
- Sponsor's protocol ID
- 326
- Other IDs
- U01HL072299, U01HL072028, U01HL072072, U01HL072191, U01HL072196, U01HL072248, U01HL072289, U01HL072290
- Status last verified
- Jun 2014
- First submitted
- 3 Oct 2005
- Last updated
- 6 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hemostasis and Invasive Procedures (SHIP: A TMH CTN Study)
- ClinicalTrials.gov ID
- NCT00233246
- Acronym / sponsor ID
- 326
- Conditions
- Blood Coagulation Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never activated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Transfusion Medicine/Hemostasis Clinical Research Network
- Study start
- Mar 2006
- First posted
- 5 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare patients with mild to moderate prolongation of the INR test who receive FFP infusions prior to invasive hepatobiliary procedures for bleeding complications to patients who do not receive FFP infusions. Bleeding complications will be defined as meeting one or more of the following:
- Intrahepatic hematoma greater than 1 ml/kg of patient weight as seen on post-procedure ultrasound examination performed between 4 to 30 hours after the procedure.
- Greater than 1.6g/dL hemoglobin decline measured within 4 to 30 hours post-procedure compared with the pre-procedure value, in the absence of another identified bleeding source to account for the hemoglobin drop.
- Need for transfusion of packed red blood cells for procedure-related bleeding while in the study.
The secondary endpoints of this study will be: 1) The need to perform subsequent procedures (angiography, embolization, additional imaging study including computerized tomography (CT) scan, surgery) to diagnose or to arrest procedure-related bleeding OR the need for subsequent medical therapies (FFP, coagulation factor concentrates, anti-fibrinolytics) to treat procedure-related bleeding between time of procedure and the end of patient's time in the study. If necessary, the relationship of procedure or therapy to procedure-related bleeding will be assessed by an adjudication panel; 2) The predictive value of INR; 3) The effect of study treatment on change in INR; 4) The cost of preventing one bleed; 5) The predictors of bleeding other than INR; 6) The number of transfusion-associated adverse events encountered to prevent one bleed; and 7) The effect of treatment on bleeding grade.
Detailed description
BACKGROUND:
It is important to determine whether or not prophylactic FFP is necessary for patients with mild to moderate elevation of the INR who require an invasive procedure. It is also important to establish whether routine pre-procedure coagulation tests are predictive of bleeding outcomes at the time of a significant invasive procedure. Although prophylactic FFP is often given to such patients before invasive procedures, there is little evidence to show that pre-procedure INR in this range is predictive of procedure-related bleeding or that prophylactic FFP reduces this risk.
DESIGN NARRATIVE:
After obtaining consent and verifying eligibility requirements, the study staff will randomize the patient to one of two treatment groups. One group will receive a prophylactic FFP infusion before the hepatobiliary procedure. The other group will not receive prophylactic FFP.
The dose of FFP will be approximately 10 ml/kg. The dose of FFP for each patient will be determined in one of two ways in accordance with local policies: 1) rounding to the nearest integer number of units (Method 1); or 2) using split units (Method 2). The method chosen may vary between patients (e.g., a physician might decide to dose adult patients by rounding to the nearest integer number of units and to dose pediatric patients using split units).
Method 1: The dose of FFP will be the number of units that comes closest to a dose of 10 ml/kg, determined as follows: nearest integer to (10 x weight in kg)/200. Decimals .5 and higher should be rounded up to the next integer. Decimals less than .5 should be rounded down (e.g., a 70 kg patient would receive 4 units, while a 69 kg patient would receive 3 units).
Method 2: The dose of FFP will be chosen in order to come as close as possible to a dose of 10 ml/kg, and can contain either full units, split units, or a combination thereof.
After the FFP infusion (if any) and within 2 hours prior to the hepatobiliary procedure, blood will be drawn for laboratory tests and for the repository. Although Study of Hemostasis and Invasive Procedures (SHIP) will not be a truly blinded study, the clinicians performing the hepatobiliary procedure and the radiology team performing the post-procedure ultrasound will not be told whether the participant received prophylactic FFP. They will also not know the results of the immediate pre-procedure Prethrombin Time (PT)/INR and Partial Thomboplastin Time (PTT) tests.
Participants in the study may not be treated with any other systemic hemostatic agents prior to the procedure. Local hemostatic treatments may be used during the procedure, according to standard practice. The invasive hepatobiliary procedure techniques, all other concomitant treatments and interventions, and all post-procedure treatments and interventions are at the discretion of the treating physicians. Participants will be followed for clinical evidence of bleeding and will be treated as needed for any bleeding that may occur.
Repository samples will only be used for genetic and protein tests of hemostasis, coagulation, and fibrinolysis.
SHIP is designed as a one-sided non-inferiority study. The null hypothesis is that the proportion of patients not given prophylactic FFP who meet the criteria for the bleeding endpoint is at least .04 higher than the proportion of patients given prophylactic FFP who meet the criteria for the bleeding endpoint. The goal of this study is to determine whether there is strong evidence that the difference between the two treatment plans is not that large.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing one of the following percutaneous abdominal or transjugular invasive procedures: liver biopsy; liver-biliary abscess drainage; biliary tree drainage; or radio-frequency ablation of hepatic tumor
- Platelet count greater than or equal to 70,000/microliter
- INR greater than or equal to 1.3 and less than or equal to 1.9 (must not be based on a sample drawn within 24 hours of any prior FFP treatment)
- A PTT less than or equal to 50 sec
Key exclusion criteria (9 listed)
- Use of warfarin, heparin, low molecular weight heparin, or other anticoagulant therapy within 5 days of the planned procedure (exceptions: prophylactic heparin injections into central venous catheters for catheter maintenance, prophylactic heparin (standard or low-dose) for prevention of deep venous thrombosis, and/or aspirin)
- History of severe allergic reaction to plasma products
- Use of any of the following second-generation anti-platelet agents: abciximab, tirofiban, clopidogrel, or ticlopidine
- Currently receiving any dialysis
- History of clinically significant bleeding diathesis, including Hemophilia A or B, von Willebrand's Disease, or congenital Factor VII deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFP Infusion | Procedure or surgery | – |
Primary outcome
Clinically significant bleeding (measured 4 to 30 hours after invasive hepatobiliary procedure)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Assmann, PhD principal investigator
New England Research Institutes, Inc.
Mark Brecher, MD principal investigator
University of North Carolina Hospital
George Buchanan, MD principal investigator
University of Texas SW Medical Center
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FFP Infusion in people with Blood Coagulation Disorders, run by Massachusetts General Hospital at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant bleeding (measured 4 to 30 hours after invasive hepatobiliary procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014.