Clinical trial · Observational
Hemostasis Alterations in Neurosurgical Patients
Prospective Study on Hemostasis Alterations in Patients Undergoing Neuro Surgical Glioma Resection Acronym: (ABCD Study: Acute Brain Coagulopathy Development Study)
NCT02652897CI-TRIAL-00035953ABCDunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective, observational study aimed to investigate the specific hemostatic alterations in patients undergoing glial tumor resection.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acquired Platelet Function Disorder | — | UNRESOLVED | — |
| Coagulopathy | — | UNRESOLVED | — |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Surgery | — | UNRESOLVED | — |
| Thromboelastometry | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exposure to colon resection surgery | Procedure | — | UNRESOLVED |
| Exposure to glioma resection surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Exposure to glioma resection surgery
- description
- Patients undergoing elective glioma resection
- interventionNames
- Procedure: Exposure to glioma resection surgery
- label
- Exposure to colon resection surgery
- description
- Patients undergoing elective colon cancer resection
- interventionNames
- Procedure: Exposure to colon resection surgery
Primary outcomes (12)
- measure
- Change of INR: International Normalized Ratio
- timeFrame
- From 24-hour before surgery (baseline) at 48-hour after surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDLeal-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 36945200
- DERIVEDLeal-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 31846350