Hemostasis Alterations in Neurosurgical Patients

Surgery Clinical Trial

— ABCD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02652897
• Other study ID #: FIS PI15 / 00512
• Status: Recruiting
• Start date: May 2016
• Est. completion date: March 2019

Study information

• Verified date: November 2018
• Source: Hospitales Universitarios Virgen del Rocío
• Contact: Santiago R. Leal-Noval, MD Ph.D
• Phone: 0034955012528
• Email: srlealnoval[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Platelet Function Disorder
• Blood Coagulation Disorders
• Coagulopathy
• Glioma
• Hemostatic Disorders
• Surgery
• Thromboelastometry

Intervention

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
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).

Locations

Country	Name	City	State
Spain	Santiago R. Leal-Noval	Seville

Sponsors (2)

Lead Sponsor	Collaborator
Santiago R. Leal-Noval	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change of coagulation factor XIII activity	Factor XIII chromogenic activity assay.	From 24-hour before surgery (baseline) at 48-hour after surgery
Secondary	perioperative bleeding	Any bleeding occurring during this period.	from surgery to hospital discharge, an average of 2 weeks.
Secondary	number of days	length of stay at ICU and hospital	from surgery to hospital discharge, an average of 2 weeks.