Thrombin Generation and Platelet Activation in Cytoreductive Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 主要终点
- Blood loss
研究概览
简要总结
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal peroperative chemotherapy (HIPEC), indicated for patients with peritoneal metastases from digestive or gynecological malignancies alike, demonstrates a considerable impact on hemostatic metabolism, both on platelet and on coagulation level. The potential hemostatic interference in CRS and HIPEC is phase dependent. This study demonstrates the combined use of ROTEM (rotational thromboelastometry), PACT (platelet activation test) and CAT (thrombin generation test) assays during CRS and HIPEC with a follow-up of 7 days postoperative.
详细描述
The purpose of this study was to quantitatively assess the impact of CRS and HIPEC, on various components of hemostasis. Routine laboratory assays such as activated clotting time, activated partial thromboplastin time, prothrombin time, or platelet count might, as demonstrated previously, insufficiently provide specificity and/or sensitivity to assess coagulation and platelet disorders. Therefore, additionally thrombin generation (TG) was analyzed by the calibrated automated thrombogram assay (CAT). Also, platelet function was quantitatively assessed by the PAC-t-UB assay and rotational thromboelastometry (ROTEM) was used to elucidate the contribution of platelets, intrinsic and extrinsic coagulation pathways in peri-operative bleeding. The hypothesis of this study was that the procedure exposed an increased thrombotic risk, resulting in a faster and increased TG and hyper platelet function?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a confirmed histological diagnosis of peritoneal disease (e.g., mesothelioma; pseudomyxoma peritonei; colorectal, ovarian, or gastric peritoneal carcinomatosis of colorectal, ovarian, or gastric cancer origin; or abdominal sarcomatosis); and
- •age <80 years; and
- •a cardiac, renal, hepatic, and bone marrow function compatible with surgery; and
- •informed written consent to participate in the study
排除标准
- •inherited coagulation abnormalities,
- •active systemic infections,
- •interstitial lung disease,
- •serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure, uncontrolled hypertension (diastolic blood pressure constantly >100 mm Hg, systolic blood pressure constantly > 180 mm Hg).
- •inadequate bone marrow function at the beginning of the trial, defined as platelet count less than <150 GPT/L or neutrophil granulocyte count less than <1.5 GPT/L.
- •inadequate renal function at the beginning of the trial, defined as GFR less than <60 ml/min,
- •inadequate liver function at the beginning of the trial, defined as bilirubin >1.5 times ULN (upper limit of normal), active hepatitis B or C infection,
- •female patients who are pregnant or breast feeding
- •participation in another therapeutic clinical trial.
结局指标
主要结局
Blood loss
时间窗: From surgical incision to 7 days postoperative
Blood loss and administration of red blood cells, fresh frozen plasma and platelets. Blood loss is quantitatively assessed based on surgical drainage volume measurements, recorded every hour. Once the surgical drains are removed (average 7 days), blood loss is quantified by hemodynamic instability and abrupt, significant decrease of hemoglobin concentration. Blood loss is assessed from the date of CRS/HIPEC surgery until 7 days postoperative or date of death from any cause, whichever came first.
次要结局
- Activated Partial Thromboplastin Time (aPTT)(From surgical incision to 7 days postoperative)
- Lag Time (Thrombin generation assay (CAT))(From surgical incision to 7 days postoperative)
- Endogenous Thrombin Potential (Thrombin generation assay (CAT))(From surgical incision to 7 days postoperative)
- P-selectin expression (Platelet activation test (PACT))(From surgical incision to 7 days postoperative)
- Red blood cell count(From surgical incision to 7 days postoperative)
- Time-to-Thrombin Peak (Thrombin generation assay (CAT))(From surgical incision to 7 days postoperative)
- Coagulation Time CT EXTEM (Rotational thromboelastometry (ROTEM))(From surgical incision to 7 days postoperative)
- Coagulation Time CT FIBTEM (Rotational thromboelastometry (ROTEM))(From surgical incision to 7 days postoperative)
- Thrombin Peak (TP) (Thrombin generation assay (CAT))(From surgical incision to 7 days postoperative)
- A5 EXTEM (Rotational thromboelastometry (ROTEM))(From surgical incision to 7 days postoperative)
- A5 FIBTEM (Rotational thromboelastometry (ROTEM))(From surgical incision to 7 days postoperative)
- Maximum Lysis (ML) FIBTEM Rotational thromboelastometry (ROTEM)(From surgical incision to 7 days postoperative)
- White blood cell count(From surgical incision to 7 days postoperative)
- Platelet count(From surgical incision to 7 days postoperative)
- Fibrinogen levels(From surgical incision to 7 days postoperative)
- Prothrombin Time (PT)(From surgical incision to 7 days postoperative)
- A30 HEPTEM (Rotational thromboelastometry (ROTEM))(From surgical incision to 7 days postoperative)
- Alpha EXTEM (Rotational thromboelastometry (ROTEM))(From surgical incision to 7 days postoperative)
- Maximum Lysis (ML) EXTEM Rotational thromboelastometry (ROTEM)(From surgical incision to 7 days postoperative)
- αIIbβ3 activation (Platelet activation test (PACT))(From surgical incision to 7 days postoperative)
- A5 HEPTEM (Rotational thromboelastometry (ROTEM))(From surgical incision to 7 days postoperative)
- Alpha HEPTEM (Rotational thromboelastometry (ROTEM))(From surgical incision to 7 days postoperative)
- Coagulation Time CT HEPTEM (Rotational thromboelastometry (ROTEM))(From surgical incision to 7 days postoperative)
- Clot Formation Time CFT HEPTEM (Rotational thromboelastometry (ROTEM)(From surgical incision to 7 days postoperative)
- Maximum Lysis (ML) HEPTEM Rotational thromboelastometry (ROTEM)(From surgical incision to 7 days postoperative)
- A30 EXTEM (Rotational thromboelastometry (ROTEM))(From surgical incision to 7 days postoperative)
- A30 FIBTEM (Rotational thromboelastometry (ROTEM))(From surgical incision to 7 days postoperative)
- Alpha FIBTEM (Rotational thromboelastometry (ROTEM))(From surgical incision to 7 days postoperative)
- Clot Formation Time CFT EXTEM (Rotational thromboelastometry (ROTEM)(From surgical incision to 7 days postoperative)
- Clot Formation Time CFT FIBTEM (Rotational thromboelastometry (ROTEM)(From surgical incision to 7 days postoperative)
研究者
Sven Van Poucke
Medical Doctor, Anesthesiologist, Emergency Physician
Ziekenhuis Oost-Limburg