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Background: Advanced pancreatic ductal adenocarcinoma (aPDAC) patients have a lifetime all type thromboembolic event (ATTE) rate of 25- 35%. Efficacy and safety of increased dose primary thromboprophylaxis (IDPTP) with low molecular heparin (LMWH) given for 3 months has been shown in two prospective randomized trials. Objectives: To report on efficacy -reduction of all type thromboembolic events (ATTE)-, safety -incidence of Major Bleeding (MB)- and compliance in a single-centre cohort of receiving first line chemotherapy and LMWH-IDPTP.
Methods: From May 2009 to October 2016, eighty two patients received IDPTP –LMWH with dalteparin. Schedule: 55kg and below: 7500 IU, between 55 and 80kg: 10,000 IU, above 80kg: 12,500 IU. MB is reported using the International Society of Thrombosis and Haemostasis (ISTH) criteria. ATTE was defined as any arterial or venous event, incidental or clinically symptomatic, including visceral VTE.
Results: Mean and median time on dalteparin was 10.2 (95%CI 8.1, 12.4) and 8.0 (95%CI 6.2, 9.7) months respectively. ATTE was observed in 7 (8.5%) of patients, with a median time on IDPTP of 6.2 months (95% CI 10.0, 13.2). MB was seen in 10 (12.2%) patients with a median time on IDPTP of 4.5 months (95% CI 1.6--7.4). Six major bleeds (60%) were the direct or indirect result of aPDAC. Eighty-one patients had died at the time of data collection with a median overall survival time of 8.7 months (95%CI 6.4, 11.0). Thromboembolism and bleeding were late events. No impact of thromboembolism or bleeding on overall survival was observed.
Conclusions: IDPTP-dalteparin was associated with lower ATTE occurrence rates than expected and comparable major bleeding rates. ATTE and MB were late events; the majority of MB was from direct or indirect result of locally progressing aPDAC. Since these conditions can frequently arise in aPDAC, IDPTP should be regularly reviewed beyond 3 months.
Keywords
Pancreatic Cancer, Thromboprophylaxis, Dalteparin, Ambulatory, Chemotherapy
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CURRENT STATUS: Published
View the published article at Thrombosis Journal.
Version 2
Posted 18 May, 2020
No community comments so far
Editorial decision: Accept
On 08 May, 2020
Editor assigned
On 04 May, 2020
Submission checks complete
On 03 May, 2020
Editor invited
On 03 May, 2020
No comments provided
Editorial decision: Minor revision
On 08 Apr, 2020
Review #3 received
Received 07 Apr, 2020
Review #2 received
Received 07 Apr, 2020
Reviewer #3 agreed
On 23 Mar, 2020
Reviewer #2 agreed
On 20 Mar, 2020
Review #1 received
Received 18 Mar, 2020
Reviewers invited
Invitations sent on 05 Mar, 2020
Reviewer #1 agreed
On 05 Mar, 2020
Editor assigned
On 03 Mar, 2020
Submission checks complete
On 02 Mar, 2020
Editor invited
On 02 Mar, 2020
First submitted
On 01 Mar, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Oncology
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See the published version of this preprint at Thrombosis Journal.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Thrombosis Journal.
Version 2
Posted 18 May, 2020
No community comments so far
Editorial decision: Accept
On 08 May, 2020
Editor assigned
On 04 May, 2020
Submission checks complete
On 03 May, 2020
Editor invited
On 03 May, 2020
No comments provided
Editorial decision: Minor revision
On 08 Apr, 2020
Review #3 received
Received 07 Apr, 2020
Review #2 received
Received 07 Apr, 2020
Reviewer #3 agreed
On 23 Mar, 2020
Reviewer #2 agreed
On 20 Mar, 2020
Review #1 received
Received 18 Mar, 2020
Reviewers invited
Invitations sent on 05 Mar, 2020
Reviewer #1 agreed
On 05 Mar, 2020
Editor assigned
On 03 Mar, 2020
Submission checks complete
On 02 Mar, 2020
Editor invited
On 02 Mar, 2020
First submitted
On 01 Mar, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Oncology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Thrombosis Journal.
Background: Advanced pancreatic ductal adenocarcinoma (aPDAC) patients have a lifetime all type thromboembolic event (ATTE) rate of 25- 35%. Efficacy and safety of increased dose primary thromboprophylaxis (IDPTP) with low molecular heparin (LMWH) given for 3 months has been shown in two prospective randomized trials. Objectives: To report on efficacy -reduction of all type thromboembolic events (ATTE)-, safety -incidence of Major Bleeding (MB)- and compliance in a single-centre cohort of receiving first line chemotherapy and LMWH-IDPTP.
Methods: From May 2009 to October 2016, eighty two patients received IDPTP –LMWH with dalteparin. Schedule: 55kg and below: 7500 IU, between 55 and 80kg: 10,000 IU, above 80kg: 12,500 IU. MB is reported using the International Society of Thrombosis and Haemostasis (ISTH) criteria. ATTE was defined as any arterial or venous event, incidental or clinically symptomatic, including visceral VTE.
Results: Mean and median time on dalteparin was 10.2 (95%CI 8.1, 12.4) and 8.0 (95%CI 6.2, 9.7) months respectively. ATTE was observed in 7 (8.5%) of patients, with a median time on IDPTP of 6.2 months (95% CI 10.0, 13.2). MB was seen in 10 (12.2%) patients with a median time on IDPTP of 4.5 months (95% CI 1.6--7.4). Six major bleeds (60%) were the direct or indirect result of aPDAC. Eighty-one patients had died at the time of data collection with a median overall survival time of 8.7 months (95%CI 6.4, 11.0). Thromboembolism and bleeding were late events. No impact of thromboembolism or bleeding on overall survival was observed.
Conclusions: IDPTP-dalteparin was associated with lower ATTE occurrence rates than expected and comparable major bleeding rates. ATTE and MB were late events; the majority of MB was from direct or indirect result of locally progressing aPDAC. Since these conditions can frequently arise in aPDAC, IDPTP should be regularly reviewed beyond 3 months.
Figure 1
Figure 2
Figure 3
Figure 4
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