Clinical trial · Interventional
The Effects of Hemodilution Methods in Patients Undergoing Primary Debulking Gynaecological Surgery
The Effects of Two Hemodilution Methods on Vascular Endothelial Function in Patients Undergoing Primary Debulking Gynaecological Surgery
- 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)
Primary cytoreductive surgery for ovarian cancer is an ideal setting to evaluate endothelial function under ANH and AHH, as the procedure is associated with moderately high blood loss. As the technique has not yet been described in this setting, investigators designed a pilot study to evaluate ANH and AHH in patients planned to undergo primary cytoreduction during perioperative period, with the intent of proceeding to a randomized trial if results were favorable.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasm Epithelial | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acute hypervolemic hemodilution (AHH) | Other | — | UNRESOLVED |
| acute normovolemic hemodilution (ANH) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Control Group
- description
- In control group ，patients had undergone similar surgical and anesthesia procedures in the same time period but whose hemodynamic management was carried out according to the clinical decision of the attending anesthesiologist.
- type
- OTHER
- label
- acute normovolemic hemodilution (ANH)
- description
- Before anesthesia induction, in the ANH Group, blood was withdrawn at a speed of 25-30ml/min from radial artery and stored in standard collection bags. The volume of blood to be removed during ANH was calculated using an established formula as follows: V = EBV (H0 - Ht) / H. During collection, a tilt rocker scale was used to rock, mix, and weigh the blood. To maintain euvolemia, half of the blood volume removed was replaced with 6% hydroxyethyl starch 130/0.4 with medium molecular weight at a 1:1 ratio and half was replaced with crystalloid at a 1:2 ratio. The autologous blood was returned to patients if the intraoperative transfusion trigger (Hb \<8.0g/dl) was reached or at the completion of the operation.
- interventionNames
- Other: acute normovolemic hemodilution (ANH)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical diagnosis of advanced primary epithelial ovarian 2. No comorbidities nor functional limitations (ASA Grade II due to high tumor load) 3. Serum hemoglobin (Hb) before surgery ≥ 11g/dl 4. Hematocrit (Hct) ≥ 35% 5. Quantity of platelets ≥ 100 × 109 /L Exclusion Criteria: 1. Age \<18 or \>65 years 2. Body mass index \<20 and \>30 kg/m2 3. Duration of surgery \<180 min 4. Severe cardiovascular disease, liver and kidney disease 5. Thromboembolism history
References
Publications (0)
Data not yet available