NCT02652897

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

2.8 years

First QC Date

December 18, 2015

Last Update Submit

November 26, 2018

Conditions

GliomaCoagulopathyAcquired Platelet Function DisorderThromboelastometrySurgery

Keywords

bleedingclotting testsneurosurgeryclotting timemaximum clot firmnesskineticslysisprimary hemostasisplatelet dysfunctioncoagulation

Outcome Measures

Primary Outcomes (12)

  • Change of INR: International Normalized Ratio

    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).

    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).

    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)

    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

    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)

    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)

    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)

    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)

    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).

    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)

    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

    Factor XIII chromogenic activity assay.

    From 24-hour before surgery (baseline) at 48-hour after surgery

Secondary Outcomes (2)

  • perioperative bleeding

    from surgery to hospital discharge, an average of 2 weeks.

  • number of days

    from surgery to hospital discharge, an average of 2 weeks.

Study Arms (2)

Exposure to glioma resection surgery

Patients undergoing elective glioma resection

Procedure: Exposure to glioma resection surgery

Exposure to colon resection surgery

Patients undergoing elective colon cancer resection

Procedure: Exposure to colon resection surgery

Interventions

Exposure to glioma resection surgeryPROCEDURE

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 glioma resection surgery
Exposure to colon resection surgeryPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santiago R. Leal-Noval

Seville, 41013, Spain

RECRUITING

Related Publications (2)

  • Leal-Noval SR, Cuenca DX, Diaz A, Fernandez-Pacheco J, Garcia-Garmendia JL, Casado M. Whole Blood Platelet Aggregation Assessed by ROTEM Platelet Equipment in Healthy Volunteers from Southern Europe: A Verification Study. J Appl Lab Med. 2023 May 4;8(3):551-558. doi: 10.1093/jalm/jfad008.

    PMID: 36945200DERIVED

  • Leal-Noval SR, Fernandez-Pacheco J, Casado-Mendez M, Cancela P, Narros JL, Arellano-Orden V, Dusseck R, Diaz-Martin A, Munoz-Gomez M. A prospective study on the correlation between thromboelastometry and standard laboratory tests - influence of type of surgery and perioperative sampling times. Scand J Clin Lab Invest. 2020 May;80(3):179-184. doi: 10.1080/00365513.2019.1704051. Epub 2019 Dec 17.

    PMID: 31846350DERIVED

MeSH Terms

Conditions

GliomaHemostatic DisordersHemorrhageThrombosis

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and Thrombosis

Study Officials

  • Santiago R. Leal-Noval, MD Ph.D

    University Hospital "Virgen del Rocío", Seville, Spain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Santiago R. Leal-Noval, MD Ph.D

CONTACT

0034955012528srlealnoval@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Santiago R. Leal-Noval, MD, PhD, Critical Care specialist

Study Record Dates

First Submitted

December 18, 2015

First Posted

January 12, 2016

Study Start

May 1, 2016

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

November 27, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)