Clinical trial · Observational
Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy
Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy: A Retrospective Cohort Study
- 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)
Project Summary: Retrospective Cohort Study 1. Core ObjectiveThe primary goal is to determine if the volume of Hydroxyethyl Starch (HES) 130/0.4 (specifically Voluven® or Volulyte®) administered during the removal of giant meningiomas (tumors \> 5 cm) increases the risk of postoperative complications. 2. Research Question Does the volume of intraoperative HES solution influence the rate of re-bleeding (requiring a second surgery within 48 hours) or the development of Acute Kidney Injury (AKI) within 7 days after the initial craniotomy?Outcomes: 3. Outcomes Primary: Incidence of re-bleeding at the tumor bed requiring re-operation within 48 hours Secondary: New-onset postoperative AKI within 7 days (defined by KDIGO criteria)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Meningioma of Brain | — | UNRESOLVED | — |
| Meningioma Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Exposed Group
- description
- Patients who received HES during surgery
- interventionNames
- Other: exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4
- label
- Non-Exposed Group
- description
- Patients who did not receive HES (received only crystalloids or other fluids).
- interventionNames
- Other: exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4
Primary outcomes (1)
- measure
- The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours
- timeFrame
- 7 days
- description
- The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Inclusion CriteriaTo be included in the study, participants must meet all of the following requirements:Age: Patients must be at least 18 years old. Diagnosis: Patients must be diagnosed with a meningioma. Tumor Size: The tumor must be classified as "giant," defined as having a diameter of 5 cm or larger as seen on a CT scan. Surgery Type: Patients must have undergone a craniotomy to remove the tumor. Timeframe: The surgery must have occurred between the years 2016 and 2024 Exclusion Criteria: * Exclusion CriteriaPatients will be excluded from the study if they meet any of the following conditions: Recurrent Cases: Patients with a recurrent meningioma (rather than a first-time surgery). Emergency Cases: Patients requiring an emergency craniotomy. Pregnancy: Any patient who is pregnant. Major Complications: Patients who experienced cardiac arrest during the surgery.
References
Publications (13)
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- RESULTBeltrame JF, Tavella R, Zeitz CJ. Beyond Structural Angiography: The Emergence of Functional Coronary Angiography. J Am Coll Cardiol. 2022 Jun 21;79(24):2379-2382. doi: 10.1016/j.jacc.2022.04.014. No abstract available. PMID 35710188
- RESULTPodcast: Enigmatic neutron stars may soon give up their secrets. Nature. 2020 Jun 15. doi: 10.1038/d41586-020-01424-3. Online ahead of print. No abstract available. PMID 34127830
- RESULTBonnesen B, Sivapalan P, Jordan A, Pedersen JW, Bergsoe CM, Eklof J, Toennesen LL, Jensen SG, Naqibullah M, Saghir Z, Jensen JS. Risk of Malignancy in Patients with Asthma-COPD Overlap Compared to Patients with COPD without Asthma. Biomedicines. 2022 Jun 21;10(7):1463. doi: 10.3390/biomedicines10071463. PMID 35884768
- RESULTShanmugam S. Inverse Electrode Placement May Help to Improve Electrotherapeutic Effects in the Field of Chronic Pain Management. Korean J Pain. 2016 Jul;29(3):202-4. doi: 10.3344/kjp.2016.29.3.202. Epub 2016 Jul 1. No abstract available. PMID 27413488
- RESULTDisseldorp DJ, Poeze M, Hannemann PF, Brink PR. Is Bone Grafting Necessary in the Treatment of Malunited Distal Radius Fractures? J Wrist Surg. 2015 Aug;4(3):207-13. doi: 10.1055/s-0035-1558831. PMID 26261748
- RESULTSlawin J, Kubler P, Szczepanski A, Piatek J, Stepkowski M, Reczuch K. Radial artery occlusion after percutaneous coronary interventions - an underestimated issue. Postepy Kardiol Interwencyjnej. 2013;9(4):353-61. doi: 10.5114/pwki.2013.38865. Epub 2013 Nov 18.