Hemostasis Alterations in Neurosurgical Patients (ABCD)

November 26, 2018 updated by: Santiago R. Leal-Noval

Prospective Study on Hemostasis Alterations in Patients Undergoing Neuro Surgical Glioma Resection Acronym: (ABCD Study: Acute Brain Coagulopathy Development Study)

Prospective, observational study aimed to investigate the specific hemostatic alterations in patients undergoing glial tumor resection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Brain parenchyma express tissue factor and other coagulation factors in high concentrations. In addition, neuro critical patients (NCP) may present platelet dysfunction, hyperfibrinolysis, hypo coagulation and / or hyper coagulation status, early after the injury. It is not known whether these alterations of hemostasis are due to a specific brain response to aggression, or they are included into a systemic response. This prospective, observational study is aimed to investigate the coagulation disorders specifically associated with cerebral aggression.

This is a prospective, cohort study including (calculated sample size) a study group of patients undergoing elective surgery (glial tumors) and other one undergoing colo rectal surgery. Alterations of the hemostasis will be evaluated by clotting tests, thromboelastometry and tests for platelet function. Samples will be drawn before and after surgical procedures. Multiple statistical comparisons intra and inter groups will be performed.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41013
        • Recruiting
        • Santiago R. Leal-Noval
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients undergoing elective glioma (study group) and colon (control group) surgeries.

Description

Inclusion Criteria:

  • Patients undergoing elective surgeries: glioma or colon cancer resections.

Exclusion Criteria:

  • Severe bleeding leading to patient's' death.
  • Incomplete tumor resection.
  • Peri operative complications leading to severe bleeding or prolonged ICU or hospital stay.
  • Peri operative blood components transfusion.
  • Peri operative transfusion of concentrate coagulation factors.
  • Intake of anti coagulant and / or antiaggregant drugs 7 days before surgery.
  • History of coagulopathy.
  • Inform consent denied for patients or relatives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposure to glioma resection surgery
Patients undergoing elective glioma resection
Procedure: Exposure to glioma resection surgery
The following blood samples will be drawn for hemostasis evaluation: 1. Conventional clotting tests, 2. Rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM; 3. Platelet function as assessed by PFA-200 for; and 4. Platelet function as assessed by ara-tem, adp-tem and trap-tem. All the analyses will be performed before (within a period 24-h before surgery) and after (within of the following periods: 2 h, 24 h and 48 h after surgery).
Exposure to colon resection surgery
Patients undergoing elective colon cancer resection
Procedure: Exposure to colon resection surgery
The following blood samples will be drawn for hemostasis evaluation: 1. Conventional clotting tests, 2. Rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM; 3. Platelet function as assessed by PFA-200 for; and 4. Platelet function as assessed by ara-tem, adp-tem and trap-tem. All the analyses will be performed before (within a period 24-h before surgery) and after (within of the following periods: 2 h, 24 h and 48 h after surgery).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of INR: International Normalized Ratio
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing INR (clotting tests) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
From 24-hour before surgery (baseline) at 48-hour after surgery
Change of aPTT: activated partial thromboplastin time (seconds).
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing aPTT (clotting tests) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
From 24-hour before surgery (baseline) at 48-hour after surgery
Change of CT / EXTEM: clotting time (seconds).
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing CT / EXTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
From 24-hour before surgery (baseline) at 48-hour after surgery
Change of MCF / EXTEM: maximum clot firmness (mm)
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing MCF / EXTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
From 24-hour before surgery (baseline) at 48-hour after surgery
Change of ML / EXTEM: Maximum lysis (%) percentage of clot which has actually lysed
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing ML (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
From 24-hour before surgery (baseline) at 48-hour after surgery
Change of col EPI (PFA-200): collage epinephrine bitartrate ( seconds)
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing col EPI (measured by platelet function analyzer : PFA-200 test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
From 24-hour before surgery (baseline) at 48-hour after surgery
Change of ara-tem / ROTEM values : platelet activation with arachidonic acid (ohm)
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing A6 (amplitude at 6 minutes, ohm), MS (maximum slope, ohm/min), and AUC (area under curve, ohm* min), all of then measured by platelet function analyzer ROTEM will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
From 24-hour before surgery (baseline) at 48-hour after surgery
Change of adp-tem / ROTEM values : platelet activation with adenosine diphosphate (ohm)
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing A6 (amplitude at 6 minutes, ohm), MS (maximum slope, ohm/min), and AUC (area under curve, ohm* min), all of then measured by platelet function analyzer ROTEM will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
From 24-hour before surgery (baseline) at 48-hour after surgery
Change of trap-tem / ROTEM values : platelet activation with thrombin activating peptide (ohm)
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing A6 (amplitude at 6 minutes, ohm), MS (maximum slope, ohm/min), and AUC (area under curve, ohm* min), all of then measured by platelet function analyzer ROTEM will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
From 24-hour before surgery (baseline) at 48-hour after surgery
Change of CT / FIBTEM: clotting time (seconds).
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing CT / FIBTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
From 24-hour before surgery (baseline) at 48-hour after surgery
Change of MCF / FIBTEM: maximum clot firmness (mm)
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing MCF / FIBTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
From 24-hour before surgery (baseline) at 48-hour after surgery
Change of coagulation factor XIII activity
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Factor XIII chromogenic activity assay.
From 24-hour before surgery (baseline) at 48-hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
perioperative bleeding
Time Frame: from surgery to hospital discharge, an average of 2 weeks.
Any bleeding occurring during this period.
from surgery to hospital discharge, an average of 2 weeks.
number of days
Time Frame: from surgery to hospital discharge, an average of 2 weeks.
length of stay at ICU and hospital
from surgery to hospital discharge, an average of 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santiago R. Leal-Noval

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Santiago R. Leal-Noval, MD Ph.D, University Hospital "Virgen del Rocío", Seville, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ANTICIPATED)

February 1, 2019

Study Completion (ANTICIPATED)

March 1, 2019

Study Registration Dates

First Submitted

December 18, 2015

First Submitted That Met QC Criteria

January 8, 2016

First Posted (ESTIMATE)

January 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIS PI15 / 00512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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