Coagulation Changes in Trauma Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Proctor, University of Miami
ClinicalTrials.gov Identifier:
NCT00795743
First received: November 19, 2008
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

Hypothesis to be tested: placement of a central venous catheter will induce a systemic hypercoagulable state. To determine this, the investigators will measure thromboelastography (TEG), PT(prothrombin time), PTT (partial thromboplastin time), Prothrombin Fragment 1.2, Factor VIII, and VonWillebrand's Factor. In addition, duplex ultrasound will be performed to correlate the laboratory coagulation values with functional changes (i.e. deep venous thrombosis).


Condition
Deep Vein Thrombosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Central Venous Catheters on Systemic Coagulation

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Coagulopathy [ Time Frame: 3 hours surrounding placement of catheter ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Detailed Description:

We will enroll all patients who will be getting a Central Venous Catheter (CVC) placed either in the PICC Insertion Room or in a surgical intensive care unit who are undergoing emergent central venous catheter placement for a medically indicated reason. All patients who have not had a previous central line or will be getting their catheter exchanged over guide wire are eligible.

At Baseline:

We intend to evaluate the patient for a Deep Vein Thrombosis by conducting a duplex ultrasound of the lower extremities prior to line insertion. We will also collect one sample of blood at baseline within 3 hours of insertion.

During CVC Insertion:

One sample of blood will be collected during CVC insertion.

Follow Up:

The last blood sample will be collected soon after CVC insertion (approximately 3hrs). Blood samples will only be drawn when we are available to collect them. Thus, this is defined as a "sample of convenience". We will also conduct another duplex ultrasound of the extremities after CVC insertion for evaluation of DVT.

Data will be collected on the duplex ultrasound result, the type of central line and the exact insertion site. Should a DVT be found, the attending physician will be made aware according to clinical protocol.

Normally, at the moment of central venous puncture, 5cc of blood is aspirated and wasted to confirm correct placement of the needle tip before placement of the guidewire. For the intended study, instead of wasting that blood, we will save 500 microliters of it for coagulation analysis. Immediately after the catheter is inserted over the guidewire, a chest x-ray is obtained to verify position of the catheter. At this point, each port of the central venous catheter is aspirated and wasted before infusion through the central venous catheter. For the purpose of this study, we will save 500 microliters of that wasted blood for coagulation analysis. To clarify, the second 500 microliters will be drawn through the newly placed central venous catheter ports and saved (instead of being drawn and wasted). Drawing back on each port before infusing is standard practice. This second sample will contain a small amount of saline, but, based on a few trials in the animal lab, this saline is unlikely to effect the coagulation analysis.

In summary, we intend to visit the patient 3 times over approximately a 4 hour period for the purpose of collecting blood that would normally otherwise be wasted (a total of 1500 microliters). This will be done only on patients who are undergoing the procedure for for a medically indicated reason and medical care will not be changed, affected, or otherwise altered based on involvement in this study. Our purpose is simply to collect 3 samples of blood during emergent central venous catheter placement that would otherwise be wasted into the biohazard container.

We will use this blood to assay prothrombin time, partial thromboplastin time, thromboelastography, Prothrombin Fragment 1.2, Factor VIII, and VonWillebrand's Factor.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

PAtients requiring placement of a central venous catheter.

Criteria

Inclusion Criteria:

  • All patients undergoing placement of a central venous catheter.

Exclusion Criteria:

  • Age under 18 or known coagulation disorder (inherited or pharmacologic).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795743

Locations
United States, Florida
Ryder Trauma Center
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Kenneth G Proctor, PhD University of Miami
  More Information

Publications:
Responsible Party: Kenneth Proctor, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00795743     History of Changes
Other Study ID Numbers: 20070692
Study First Received: November 19, 2008
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Central Venous Catheterization
coagulopathy
thromboelastography

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014